CD205SHUTTLE: MEN1309 I.v. Infusion in Pts With CD205-positive Metastatic Solid Tumors and Relapsed or Refractory NHL Ph I Study
Sponsor
Menarini Group (Industry)
Overall Status
Terminated
CT.gov ID
NCT03403725
Collaborator
(none)
28
7
1
28.4
4
0.1
Study Details
Study Description
Brief Summary
The purpose of this clinical trial is to identify the highest dose of MEN1309 drug with acceptable safety profile and that can be used in patients affected by CD205-positive solid tumors and Non-Hodgkin Lymphoma
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
This clinical trial will investigate the safety and activity of MEN1309 in patients with CD205-positive metastatic solid tumors and Non-Hodgkin Lymphoma who have tried other types of treatment for cancer without adequate response (or the cancer came back). CD205 is a protein present in certain types of cancer.
This is a Phase I study, which means that it is designed to look at several dose levels of a study drug in small groups of patients to find the dose that is well-tolerated and suitable to be administered in subsequent clinical trials in patients. The clinical trial is also looking at the effectiveness of the study drug. This is the first time the study drug will be given in humans.
The clinical trial consists of two sequential parts:
-
Part 1 involves patients with CD205-positive metastatic solid tumors and the main purpose of this part of the clinical trial is to determine the highest dose of the study drug that can be used safely in these type of cancers.
-
Part 2 involves patients with CD205-positive Non-Hodgkin Lymphoma and will test doses of MEN1309 which have demonstrated to be adequately tolerated in patients with solid tumors.
Patients participating to the clinical trial will take the study drug as intravenous infusion once every 3 weeks. The clinical trial includes four periods: a pre-screening period (to check if tumor is positive for CD205), a screening period (to check whether the participation to the clinical trial is right for patient), a treatment period (when patient receives the study drug), and a follow-up period (to check the health status of the patient after stopping study treatment).
Study Design
Study Type:
Interventional
Actual Enrollment
:
28 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
Cohort1 0.05mg/kg STEP 1 Solid Tumors Cohort2 0.10mg/kg STEP 1 Solid Tumors Cohort3 0.20mg/kg STEP 1 Solid Tumors Cohort4 0.40mg/kg STEP 1 Solid Tumors Cohort5 0.80mg/kg STEP 1 Solid Tumors Cohort6 1.60mg/kg STEP 1 Solid Tumors Cohort7 2.40mg/kg STEP 1 Solid Tumors Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF Cohort5 0.80mg/kg STEP 2 NHLCohort1 0.05mg/kg STEP 1 Solid Tumors Cohort2 0.10mg/kg STEP 1 Solid Tumors Cohort3 0.20mg/kg STEP 1 Solid Tumors Cohort4 0.40mg/kg STEP 1 Solid Tumors Cohort5 0.80mg/kg STEP 1 Solid Tumors Cohort6 1.60mg/kg STEP 1 Solid Tumors Cohort7 2.40mg/kg STEP 1 Solid Tumors Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF Cohort5 0.80mg/kg STEP 2 NHL
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-Label, Multicenter, Phase I Dose Escalation Study of MEN1309, a CD205 Antibody-Drug Conjugate,in Patients With CD205-Positive Metastatic Solid Tumors and Non-Hodgkin Lymphoma
Actual Study Start Date
:
Aug 28, 2017
Actual Primary Completion Date
:
Oct 22, 2019
Actual Study Completion Date
:
Jan 8, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MEN1309 (Step 1-Solid Tumors)/(Step 2-NHL) Step1: Accelerated Titration Design with 1 single pt per cohort and double dose level per cohort until grade ≥ 2 drug related toxicity. Then, study reverts to 3+3 design. Any cohort in which 1 pt experiences a DLT (along ATD or 3+3) will be expanded up to 6 pts. Step2: MTD defined in Step 1, 3 MEN1309 dose levels will be tested (MTD-2, MTD-1, and MTD), with 6 pts per each dose level. A further MTD-3 level will be explored if 2 DLTs occur at the MTD-2 dose level. |
Drug: MEN1309
MEN1309 solution for intravenous infusion once every 3 weeks
|
Outcome Measures
Primary Outcome Measures
- Maximum-Tolerated Dose (MTD) [21-day period after the first dose]
Defined as the highest dose level at which no more than 1 of 6 patients experiences a DLT during the DLT assessment window.
- Dose-Limiting Toxicity (DLT) [21-day period after the first dose]
Adverse drug reactions (ADRs) that will be assessed during Cycle 1: any grade ≥ 3 cardiac toxicity, new segmental wall-motion abnormalities, or cardiac troponin I or T elevation of grade 3 or higher; any grade ≥ 3 elevations in total bilirubin, hepatic transaminases, or ALP levels; in patients with baseline grade 2 hepatic transaminase or ALP levels, an elevation to ≥ 10 x ULN is considered a DLT; any grade 3 non-haematologic toxicity lasting > 7 days, (excluding diarrhea/nausea for which no adequate and optimal therapy has been implemented and alopecia); any grade 3 vomiting lasting > 3 days despite adequate and optimal therapy; any grade ≥ 4 non-haematologic toxicity; any grade 4 thrombocytopenia or anemia; any grade 4 neutropenia lasting > 7 days or febrile neutropenia; any treatment delay of > 2 weeks because of delayed recovery from toxicity related to MEN1309 (except for alopecia).
Secondary Outcome Measures
- Overall Survival [Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)]
Timeframe between the first study drug administration and death from any cause.
- Progression Free Survival [Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)]
The Number of days between the first study administration to the date of first documented disease progression.
- Preliminary Tumor Activity (RR) [From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study)]
Preliminary tumor activity (RR) Response Rate. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit.
- Preliminary Antitumor Activity (DCR) [From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study)]
Preliminary Antitumor Activity (DCR) Disease control Rate. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit.
- Preliminary Antitumor Activity (DOR) [From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study)]
Prliminary Antitumor Activity. Measure of the Duration of response. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit.
- MEN1309 PK Parameter Cmax [Cycle 1]
Cmax is the maximum drug concentration
- MEN1309 PK Parameter Ctrough [Pre-infusion Cycle 2]
MEN1309 PK parameter Ctrough (Predose concentration)
- MEN1309 Pharmacokinetic (PK) Parameter t1/2 [Cycle 1]
MEN1309 Pharmacokinetic (PK) parameter t1/2 (terminal serum half-life)
- MEN1309 Pharmacokinetic (PK) Parameter AUC [Cycle 1]
MEN1309 Pharmacokinetic (PK) parameter AUC (area under curve)
- MEN1309 (PK) Parameter CL [Cycle 1]
Systemic clearance of MEN1309 Pharmacokinetic
- MEN1309 Pharmacokinetic (PK) Parameter Vd [Cycle 1]
volume of distribution based on the terminal phase
Other Outcome Measures
- Correlation of CD205 Expression in Tumors With Clinical Activity of MEN1309 Assessed According to RECIST 1.1 or Cheson Criteria (2014) [Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)]
Exploratory Endpoint: Correlation of CD205 expression in tumors with clinical activity of MEN1309 assessed according to RECIST 1.1 or Cheson Criteria (2014) in terms of Response Rate, Disease control rate, duration of response, overall survival, and progression free survival. N.B: No Data were available to assess this outcome.
- Incidence of Anti-MEN1309 Antibodies [Day 1 of each Cycle (each cycle is 21 days)]
Exploratory Endpoint: Immunogenicity analysis regarding the Incidence of anti-MEN1309 antibodies.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Main Inclusion Criteria:
-
Male or female patients aged ≥ 18 years.
-
Patients with:
-
confirmed diagnosis of advanced or metastatic solid tumor and diagnosis of multiple relapsed or refractory NHL;
-
progressive after last treatment received;
-
availability of archived tumor material, either as a block or slides;
-
measurable or evaluable disease by Response Evaluation Criteria in solid tumors guideline (RECIST v1.1) and by Cheson Criteria (The Lugano Classification, 2014) in NHL.
-
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
-
Neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL; haemoglobin ≥ 9 g/dL.
-
Adequate renal and hepatic laboratory assessments.
-
Life expectancy of at least 2 months.
-
Woman of childbearing potential (WOCBP) who agrees to use highly effective contraception (see Appendix I).
Main Exclusion Criteria:
-
Central nervous system involvement (excluding treated stable cerebral metastasis, not requiring therapy to control symptoms in the last 60 days).
-
Pregnant or breastfeeding women.
-
Life-threatening illnesses other than solid tumors and NHL, uncontrolled medical conditions or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety, or put the study outcomes at risk.
-
Less than 2 previous cancer treatments, including high dose chemotherapy and ASCT, for NHL unless patient refuses standard therapy and/or is not eligible for ASCT.
-
Have significant, uncontrolled, or active cardiovascular disease.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Sart Tilman | Liège | Belgium | 4000 | |
| 2 | Centro Riferimento Oncologico | Aviano | Italy | 33081 | |
| 3 | IRCCS Ospedale San Raffaele | Milano | Italy | 20132 | |
| 4 | Vall d'Hebron Barcelona Hospital | Barcelona | Spain | ||
| 5 | START Madrid. Fundacion Jimenez Diaz | Madrid | Spain | 28040 | |
| 6 | Centro Integral Oncologico Clara Campal | Madrid | Spain | 28050 | |
| 7 | NCCC Clinical Trials Pharmacy, Northern Centre for Cancer Care | Newcastle upon Tyne | United Kingdom | NE7 7DN |
Sponsors and Collaborators
- Menarini Group
Investigators
- Study Chair: Josep Tabernero Head, Medical Oncology Department, MD PhD, Vall d' Hebron Institute of Oncology (VHIO) P. Vall d'Hebron 119-129 08035 Barcelona, Spain
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Menarini Group
ClinicalTrials.gov Identifier:
NCT03403725
Other Study ID Numbers:
- MEN1309-01
First Posted:
Jan 19, 2018
Last Update Posted:
Sep 28, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Menarini Group
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | It was planned to perform this study in 7 sites across 4 European countries: Spain, Italy, Belgium, and UK. Patients were only recruited in 5 sites (3 ES, 1 IT1, 1 BE) prior to the study being stopped. The study started in date 28 August 2017 (FPI) to 19 November 2019 (LPLV). Study Termination letter was sent to authorities on 08 January 2020. |
|---|---|
| Pre-assignment Detail | Male or female patients aged ≥ 18 years. For Step 1 of the study, patients with diagnosis of advanced or metastatic solid tumor. For Step 2, patients with histologically confirmed diagnosis of relapsed or refractory NHL. In both Steps the tumor need to have a positivity (≥ 1+ IHC staining) for CD205. |
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309. |
| Period Title: Overall Study | |||||||||||
| STARTED | 1 | 1 | 1 | 1 | 1 | 6 | 6 | 3 | 3 | 4 | 1 |
| COMPLETED | 1 | 1 | 1 | 1 | 1 | 6 | 6 | 3 | 3 | 4 | 1 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved 0.05mg/kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved 0.10mg/kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved 0.20mg/kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved 0.40mg/kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved 0.80mg/kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved 1.60mg/kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved 2.40mg/kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved 3.36mg/kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved 2.40mg/kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved 2.00mg/kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved 0.80mg/kg of MEN1309. | Total of all reporting groups |
| Overall Participants | 1 | 1 | 1 | 1 | 1 | 6 | 6 | 3 | 3 | 4 | 1 | 28 |
| Age (Count of Participants) | ||||||||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
1
100%
|
1
100%
|
1
100%
|
1
100%
|
1
100%
|
4
66.7%
|
3
50%
|
2
66.7%
|
2
66.7%
|
2
50%
|
0
0%
|
18
64.3%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
33.3%
|
3
50%
|
1
33.3%
|
1
33.3%
|
2
50%
|
1
100%
|
10
35.7%
|
| Sex: Female, Male (Count of Participants) | ||||||||||||
| Female |
1
100%
|
1
100%
|
1
100%
|
1
100%
|
0
0%
|
3
50%
|
6
100%
|
3
100%
|
1
33.3%
|
2
50%
|
0
0%
|
19
67.9%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
100%
|
3
50%
|
0
0%
|
0
0%
|
2
66.7%
|
2
50%
|
1
100%
|
9
32.1%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||||||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
33.3%
|
1
25%
|
0
0%
|
2
7.1%
|
| Not Hispanic or Latino |
1
100%
|
1
100%
|
1
100%
|
1
100%
|
1
100%
|
6
100%
|
6
100%
|
3
100%
|
2
66.7%
|
3
75%
|
1
100%
|
26
92.9%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
1
100%
|
1
100%
|
1
100%
|
1
100%
|
1
100%
|
6
100%
|
6
100%
|
3
100%
|
3
100%
|
4
100%
|
1
100%
|
28
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||||||||||
| Belgium |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
100%
|
1
16.7%
|
1
16.7%
|
1
33.3%
|
1
33.3%
|
0
0%
|
0
0%
|
5
17.9%
|
| Italy |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
1
25%
|
0
0%
|
2
7.1%
|
| Spain |
1
100%
|
1
100%
|
1
100%
|
1
100%
|
0
0%
|
5
83.3%
|
5
83.3%
|
2
66.7%
|
2
66.7%
|
3
75%
|
1
100%
|
0
0%
|
| Weight (Kg) [Mean (Standard Deviation) ] | ||||||||||||
| Mean (Standard Deviation) [Kg] |
66.10
(0)
|
56.80
(0)
|
60.60
(0)
|
62.50
(0)
|
53.50
(0)
|
64.27
(17.382)
|
67.30
(15.725)
|
61.17
(8.520)
|
76.57
(15.584)
|
64.55
(8.805)
|
109.4
(0)
|
66.68
(12.886)
|
Outcome Measures
| Title | Maximum-Tolerated Dose (MTD) |
|---|---|
| Description | Defined as the highest dose level at which no more than 1 of 6 patients experiences a DLT during the DLT assessment window. |
| Time Frame | 21-day period after the first dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| MTD was evaluated only in the STEP 1 since in STEP 2 only one patient was treated. |
| Arm/Group Title | All Doses STEP 1-Solid Tumors |
|---|---|
| Arm/Group Description | All Patients with CD205-positive advanced solid tumors inlcuded in STEP1. |
| Measure Participants | 27 |
| Number [mg/Kg] |
1.6
|
| Title | Dose-Limiting Toxicity (DLT) |
|---|---|
| Description | Adverse drug reactions (ADRs) that will be assessed during Cycle 1: any grade ≥ 3 cardiac toxicity, new segmental wall-motion abnormalities, or cardiac troponin I or T elevation of grade 3 or higher; any grade ≥ 3 elevations in total bilirubin, hepatic transaminases, or ALP levels; in patients with baseline grade 2 hepatic transaminase or ALP levels, an elevation to ≥ 10 x ULN is considered a DLT; any grade 3 non-haematologic toxicity lasting > 7 days, (excluding diarrhea/nausea for which no adequate and optimal therapy has been implemented and alopecia); any grade 3 vomiting lasting > 3 days despite adequate and optimal therapy; any grade ≥ 4 non-haematologic toxicity; any grade 4 thrombocytopenia or anemia; any grade 4 neutropenia lasting > 7 days or febrile neutropenia; any treatment delay of > 2 weeks because of delayed recovery from toxicity related to MEN1309 (except for alopecia). |
| Time Frame | 21-day period after the first dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309. |
| Measure Participants | 1 | 1 | 1 | 1 | 1 | 6 | 6 | 3 | 3 | 4 | 1 |
| Number [Dose Limiting Toxicities] |
0
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
3
|
2
|
0
|
| Title | Overall Survival |
|---|---|
| Description | Timeframe between the first study drug administration and death from any cause. |
| Time Frame | Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| For Cohorts reported as 0 analyzed the patients were censored (Event Date Not available) |
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309. |
| Measure Participants | 0 | 1 | 1 | 0 | 1 | 1 | 4 | 0 | 0 | 3 | 0 |
| Mean (Standard Deviation) [Days] |
379
(0)
|
700
(0)
|
74
(0)
|
154
(0)
|
297.75
(208.73)
|
90.33
(12.66)
|
| Title | Progression Free Survival |
|---|---|
| Description | The Number of days between the first study administration to the date of first documented disease progression. |
| Time Frame | Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| For Cohorts reported as 0 analyzed the patients were censored (Event Date Not available) |
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309. |
| Measure Participants | 0 | 0 | 1 | 0 | 1 | 2 | 4 | 0 | 2 | 3 | 0 |
| Mean (Standard Deviation) [Days] |
41
(0)
|
38
(0)
|
36.5
(0.71)
|
155.5
(190.51)
|
100.5
(28.99)
|
37
(1.73)
|
| Title | Preliminary Tumor Activity (RR) |
|---|---|
| Description | Preliminary tumor activity (RR) Response Rate. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit. |
| Time Frame | From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Population:All eligible patients who receive at least 2 complete treatment cycles and have at least 1 disease assessment are to be considered evaluable for efficacy. The percentage of patient is 0% since no patient had Complete response or partial response. |
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309. |
| Measure Participants | 1 | 1 | 1 | 0 | 1 | 0 | 3 | 3 | 0 | 2 | 4 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Preliminary Antitumor Activity (DCR) |
|---|---|
| Description | Preliminary Antitumor Activity (DCR) Disease control Rate. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit. |
| Time Frame | From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Population:All eligible patients who receive at least 2 complete treatment cycles and have at least 1 disease assessment are to be considered evaluable for efficacy. Out of 11 evaluable patients, 11 patients had stable disease (SD), no complete response or partial response was observed. |
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309. |
| Measure Participants | 1 | 1 | 1 | 0 | 1 | 0 | 3 | 3 | 0 | 2 | 4 |
| Number [N. of Stable Disease/N. of Pts] |
0
|
0
|
0
|
1
|
0.33
|
0.8
|
0
|
0.25
|
| Title | Preliminary Antitumor Activity (DOR) |
|---|---|
| Description | Prliminary Antitumor Activity. Measure of the Duration of response. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit. |
| Time Frame | From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data Cannot be reported since it was not analyzed. No Patients had Complete response and Partial Response. |
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | MEN1309 PK Parameter Cmax |
|---|---|
| Description | Cmax is the maximum drug concentration |
| Time Frame | Cycle 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309. |
| Measure Participants | 1 | 1 | 1 | 1 | 1 | 6 | 6 | 3 | 3 | 4 | 1 |
| Mean (Standard Deviation) [microgram/mL] |
0.73
(0.19)
|
0.87
(0.16)
|
1.75
(0.09)
|
3.16
(0)
|
9.67
(2.03)
|
31.87
(9.11)
|
43.94
(11.25)
|
64.97
(33.40)
|
44.50
(15.79)
|
33.52
(9.29)
|
11.36
(0)
|
| Title | MEN1309 PK Parameter Ctrough |
|---|---|
| Description | MEN1309 PK parameter Ctrough (Predose concentration) |
| Time Frame | Pre-infusion Cycle 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| For Cohort 4 the treatment ended at Cycle 1 for the only subejct. |
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309. |
| Measure Participants | 1 | 1 | 1 | 0 | 1 | 6 | 6 | 3 | 3 | 4 | 1 |
| Mean (Standard Deviation) [ng/mL] |
0
(0)
|
0
(0)
|
0
(0)
|
0
(0)
|
0
(0)
|
0
(0)
|
0
(0)
|
0
(0)
|
0
(0)
|
0
(0)
|
| Title | MEN1309 Pharmacokinetic (PK) Parameter t1/2 |
|---|---|
| Description | MEN1309 Pharmacokinetic (PK) parameter t1/2 (terminal serum half-life) |
| Time Frame | Cycle 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309. |
| Measure Participants | 1 | 1 | 1 | 1 | 1 | 6 | 6 | 3 | 3 | 4 | 1 |
| Mean (Standard Deviation) [hr] |
2.66
(0)
|
3.17
(0)
|
2.38
(0)
|
16.65
(0)
|
93.90
(0)
|
18.24
(6.49)
|
16.89
(1.67)
|
27.74
(2.36)
|
15.36
(0.96)
|
17.24
(1.24)
|
15.08
(0)
|
| Title | MEN1309 Pharmacokinetic (PK) Parameter AUC |
|---|---|
| Description | MEN1309 Pharmacokinetic (PK) parameter AUC (area under curve) |
| Time Frame | Cycle 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309. |
| Measure Participants | 1 | 1 | 1 | 1 | 1 | 6 | 6 | 3 | 3 | 4 | 1 |
| Mean (Standard Deviation) [hr * microgram/mL] |
3.94
(0)
|
3.78
(0)
|
6.16
(0)
|
11.86
(0)
|
57.49
(0)
|
583.38
(213.45)
|
1038.12
(257.12)
|
2045.41
(1130.69)
|
958.94
(417.06)
|
689.33
(295.50)
|
111.44
(0)
|
| Title | MEN1309 (PK) Parameter CL |
|---|---|
| Description | Systemic clearance of MEN1309 Pharmacokinetic |
| Time Frame | Cycle 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309. |
| Measure Participants | 1 | 1 | 1 | 1 | 1 | 6 | 6 | 3 | 3 | 4 | 1 |
| Mean (Standard Deviation) [L/hr] |
0.82
(0)
|
1.46
(0)
|
1.96
(0)
|
2.06
(0)
|
0.70
(0)
|
0.20
(0.09)
|
0.17
(0.08)
|
0.13
(0.9)
|
0.21
(0.07)
|
0.22
(0.11)
|
0.78
(0)
|
| Title | MEN1309 Pharmacokinetic (PK) Parameter Vd |
|---|---|
| Description | volume of distribution based on the terminal phase |
| Time Frame | Cycle 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309. | Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309. |
| Measure Participants | 1 | 1 | 1 | 1 | 1 | 6 | 6 | 3 | 3 | 4 | 1 |
| Mean (Standard Deviation) [L] |
3.14
(0)
|
6.69
(0)
|
6.73
(0)
|
49.47
(0)
|
95.45
(0)
|
4.97
(2.5)
|
4.02
(1.32)
|
4.73
(1.80)
|
5.55
(3.24)
|
5.08
(3.08)
|
16.94
(0)
|
| Title | Correlation of CD205 Expression in Tumors With Clinical Activity of MEN1309 Assessed According to RECIST 1.1 or Cheson Criteria (2014) |
|---|---|
| Description | Exploratory Endpoint: Correlation of CD205 expression in tumors with clinical activity of MEN1309 assessed according to RECIST 1.1 or Cheson Criteria (2014) in terms of Response Rate, Disease control rate, duration of response, overall survival, and progression free survival. N.B: No Data were available to assess this outcome. |
| Time Frame | Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| N.B: No Data were available to assess this outcome. |
| Arm/Group Title | STEP1 Solid Tumor All Doses + STEP 2 NHL |
|---|---|
| Arm/Group Description | All Patients with CD205-positive advanced solid tumors inlcuded in STEP1 and all NHL patients included in STEP 2. |
| Measure Participants | 0 |
| Title | Incidence of Anti-MEN1309 Antibodies |
|---|---|
| Description | Exploratory Endpoint: Immunogenicity analysis regarding the Incidence of anti-MEN1309 antibodies. |
| Time Frame | Day 1 of each Cycle (each cycle is 21 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| For this Outcome Results are not available per Cohorts, but only on the total of patients analyzed. |
| Arm/Group Title | STEP1 Solid Tumor All Doses + STEP 2 NHL |
|---|---|
| Arm/Group Description | All Patients with CD205-positive advanced solid tumors inlcuded in STEP1 and all NHL patients included in STEP 2. |
| Measure Participants | 28 |
| ADA Positive |
10
|
| ADA Negative |
18
|
Adverse Events
| Time Frame | Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months) | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||||||
| Arm/Group Title | Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL | |||||||||||
| Arm/Group Description | Patients with CD205-advanced Solid Tumor, who recieved 0.05 mg/kg of MEN1309. | Patients with CD205-advanced Solid Tumor, who recieved 0.10 mg/kg of MEN1309. | Patients with CD205-advanced Solid Tumor, who recieved 0.20 mg/kg of MEN1309. | Patients with CD205-advanced Solid Tumor, who recieved 0.40 mg/kg of MEN1309. | Patients with CD205-advanced Solid Tumor, who recieved 0.80 mg/kg of MEN1309. | Patients with CD205-advanced Solid Tumor, who recieved 1.60 mg/kg of MEN1309. | Patients with CD205-advanced Solid Tumor, who recieved 2.40 mg/kg of MEN1309. | Patients with CD205-advanced Solid Tumor, who recieved 3.36 mg/kg of MEN1309. | Patients with CD205-advanced Solid Tumor, who recieved 2.40 mg/kg of MEN1309. | Patients with CD205-advanced Solid Tumor, who recieved 2.00 mg/kg of MEN1309. | Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved 0.80mg/kg of MEN1309. | |||||||||||
All Cause Mortality |
||||||||||||||||||||||
| Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) | 1/6 (16.7%) | 5/6 (83.3%) | 1/3 (33.3%) | 0/3 (0%) | 3/4 (75%) | 0/1 (0%) | |||||||||||
Serious Adverse Events |
||||||||||||||||||||||
| Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 1/1 (100%) | 0/1 (0%) | 1/1 (100%) | 0/1 (0%) | 5/6 (83.3%) | 5/6 (83.3%) | 3/3 (100%) | 3/3 (100%) | 2/4 (50%) | 1/1 (100%) | |||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||||
| Febrile Neutropenia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 2/6 (33.3%) | 2 | 2/6 (33.3%) | 2 | 2/3 (66.7%) | 2 | 3/3 (100%) | 3 | 2/4 (50%) | 2 | 0/1 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||||||
| Gastric Haemorrhage | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Small Intestinal Obstruction | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| General disorders | ||||||||||||||||||||||
| Disease Progression | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||||||
| Device related infection | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/1 (0%) | 0 |
| Peritonitis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Sepsis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Investigations | ||||||||||||||||||||||
| Neutrophil count decreased | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| ECOG performance Status Worsened | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||||||
| Decrease appetite | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||
| Malignant neoplasm progression | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||||||
| Aphasia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Hemiparesis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||||||||
| Renal failure | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/1 (100%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||
| Pulmunary Embolism | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Vascular disorders | ||||||||||||||||||||||
| Embolism venous | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||
| Cohort1 0.05mg/kg STEP 1 Solid Tumors | Cohort2 0.10mg/kg STEP 1 Solid Tumors | Cohort3 0.20mg/kg STEP 1 Solid Tumors | Cohort4 0.40mg/kg STEP 1 Solid Tumors | Cohort5 0.80mg/kg STEP 1 Solid Tumors | Cohort6 1.60mg/kg STEP 1 Solid Tumors | Cohort7 2.40mg/kg STEP 1 Solid Tumors | Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF | Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF | Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF | Cohort5 0.80mg/kg STEP 2 NHL | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/1 (100%) | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) | 6/6 (100%) | 6/6 (100%) | 3/3 (100%) | 3/3 (100%) | 4/4 (100%) | 1/1 (100%) | |||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||||
| Dizziness | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 2 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||||||
| Adnominal disorders | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Abdominal pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Abdominal pain upper | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Constipation | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Gastrooesphageal reflux disease | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Nausea | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 2/6 (33.3%) | 2 | 4/6 (66.7%) | 4 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 2/4 (50%) | 2 | 0/1 (0%) | 0 |
| Stomatitis | 1/1 (100%) | 2 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 2/6 (33.3%) | 3 | 2/6 (33.3%) | 2 | 3/3 (100%) | 3 | 2/3 (66.7%) | 2 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Vomiting | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 3 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| General disorders | ||||||||||||||||||||||
| Diorrhoea | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 3/6 (50%) | 5 | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Asthenia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 2/6 (33.3%) | 3 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Chest Pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Fatigue | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 3/6 (50%) | 3 | 3/6 (50%) | 3 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 2/4 (50%) | 3 | 0/1 (0%) | 0 |
| Oedema Pheripheral | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Pyrexia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/1 (0%) | 0 |
| Dyspepsia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||||||
| Urinary tract infection | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||||
| Infusion related reaction | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 2 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Investigations | ||||||||||||||||||||||
| Blood Bliriubin increased | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 3 | 0/1 (0%) | 0 |
| lymphocyte count decresed | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 2/6 (33.3%) | 2 | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Neutrophil count decreased | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 5/6 (83.3%) | 9 | 6/6 (100%) | 12 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 4/4 (100%) | 7 | 1/1 (100%) | 2 |
| Platelet count decreased | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 | 1/3 (33.3%) | 1 | 2/3 (66.7%) | 2 | 2/4 (50%) | 3 | 1/1 (100%) | 2 |
| white blood cell count decreased | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/6 (16.7%) | 2 | 2/6 (33.3%) | 2 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/1 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||||||
| Decreased appetite | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||
| Back pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||||||||||
| Depression | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/1 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||
| Dysphonia | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/1 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Corporate Director of Clinical Sciences |
|---|---|
| Organization | Menarini Ricerche SPA |
| Phone | +39 055 56809933 |
| acapriati@menarini-ricerche.it |
Responsible Party:
Menarini Group
ClinicalTrials.gov Identifier:
NCT03403725
Other Study ID Numbers:
- MEN1309-01
First Posted:
Jan 19, 2018
Last Update Posted:
Sep 28, 2021
Last Verified:
Feb 1, 2021