Sym022 (Anti-LAG-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas
Study Details
Study Description
Brief Summary
This is the first study to test Sym022 in humans. The primary purpose of this study is to see if Sym022 is safe and tolerable for patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
This study will evaluate the preliminary safety, tolerability, and dose-limiting toxicities (DLTs) of Sym022, an anti-lymphocyte activation gene 3 (anti-LAG-3) monoclonal antibody (mAb). The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of Sym022 when administered once every 2 weeks (Q2W) by intravenous (IV) infusion to patient cohorts with locally advanced/ unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available. If an MTD is not identified, a maximum administered dose (MAD) will be determined. Sym022 will be given to patients in escalating dose cohorts; each patient will be given one fixed dose level.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sym022 Sym022 will be administered at up to 4 planned dose levels. |
Drug: Sym022
Sym022 is a recombinant, fully human antibody that binds LAG-3 and blocks the LAG-3/major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Assessment of Treatment Related Adverse Events (AEs). [19 months]
Assess the safety, tolerability and dose-limiting toxicities of Sym022 on a Q2W schedule to establish the MTD and/or RP2D.
Secondary Outcome Measures
- Evaluation of the Immunogenicity of Sym022. [19 months]
Serum sampling and incidence (%) per dose level to assess the potential for anti-drug antibody (ADA) formation. Count of participants show the number of participants who were tested positive for anti-Sym022 ADA.
- Evaluation of Objective Response (OR) or Stable Disease (SD). [13 months]
Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), Response Evaluation Criteria in Lymphomas 2017 (RECIL 2017), or Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST), depending on tumor type. The numbers shown below correspond to the values related to RECIST v1.1.
- Time to Progression (TTP) of Disease. [13 months]
Based on time of enrollment to first evidence of progression on imaging studies, as assessed by RECIST v1.1, RECIL 2017, or iRECIST, depending on tumor type. The numbers shown below correspond to the values related to RECIST v1.1.
- Area Under the Concentration-time Curve in a Dosing Interval (AUC). [19 months]
Will be estimated using non-compartmental methods and actual timepoints.
- Maximum Concentration (Cmax) [0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)]
Will be derived from observed data.
- Time to Reach Maximum Concentration (Tmax) [0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)]
Will be derived from observed data.
- Trough Concentration (Ctrough) [0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)]
Will be derived from observed data.
- Terminal Elimination Half-life (T½) [0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)]
Will be estimated using non-compartmental methods and actual timepoints.
- Clearance (CL) [0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)]
Will be estimated using non-compartmental methods and actual timepoints.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female patients, ≥ 18 years of age at the time of obtaining informed consent.
-
Documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; patients with documented lymphomas.
-
Malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or nonresectability of the tumor.
-
Refractory to or intolerant of existing therapy(ies) known to provide clinical benefit.
-
Measurable or non-measurable disease according to RECIST v1.1 or RECIL 2017.
-
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
-
Not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 6 months after the last dose of study drug.
Exclusion Criteria:
-
Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug. Women of childbearing potential (WOCBP) and fertile men with WOCBP partner(s), not using and not willing to use a highly effective method of contraception.
-
Known, untreated central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression, patients with any of the above not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required.
-
Hematologic malignancies other than lymphomas.
-
Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to Cycle 1/Day 1 (C1/D1) unless adequately treated and considered stable
-
Active uncontrolled bleeding or a known bleeding diathesis
-
Clinically significant cardiovascular disease or condition
-
Significant pulmonary disease or condition
-
Current or recent (within 6 months) significant gastrointestinal (GI) disease or condition.
-
An active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.
-
History of organ transplantation (e.g. stem cell or solid organ transplant)
-
History of significant toxicities associated with previous administration of immune checkpoint inhibitors that necessitated permanent discontinuation of that therapy
-
Patients with unresolved > Grade 1 toxicity associated with any prior antineoplastic therapy, with exceptions.
-
Inadequate recovery from any prior surgical procedure, or having undergone any major surgical procedure within 4 weeks prior to C1/D1.
-
Known history of human immunodeficiency virus (HIV) or known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
-
Other Inhibitors of LAG-3
-
Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest, prior to first administration of study drug and during study
-
Any other investigational treatments within 4 weeks prior to and during study
-
Radiotherapy for target lesions within 4 weeks prior to first administration of study drug unless PD has been documented in the lesion following treatment, and during study.
-
Radiotherapy for non-target lesions within 1 week prior to first administration of study drug
-
Immunosuppressive or systemic hormonal therapy
-
Prophylactic use of hematopoietic growth factors within 1 week prior to first administration of study drug and during Cycle 1 of study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | South Texas Accelerated Research Therapeutics (START) Midwest | Grand Rapids | Michigan | United States | 49503 |
| 2 | The University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 3 | Princess Margaret Cancer Centre | Toronto | Ontario | Canada | M5G 2M9 |
Sponsors and Collaborators
- Symphogen A/S
Investigators
- Principal Investigator: Lillian Siu, MD, FRCPC, Princess Margaret Cancer Centre
Study Documents (Full-Text)
More Information
Publications
None provided.- Sym022-01
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 |
|---|---|---|---|---|
| Arm/Group Description | 0.3 mg/kg dosing of Sym022 every second week (Q2W) | 1.0 mg/kg dosing of Sym022 every second week (Q2W) | 3 mg/kg dosing of Sym022 every second week (Q2W) | 10.0 mg/kg dosing of Sym022 every second week (Q2W) |
| Period Title: Overall Study | ||||
| STARTED | 3 | 3 | 3 | 6 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 3 | 3 | 3 | 6 |
Baseline Characteristics
| Arm/Group Title | Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 0.3 mg/kg dosing of Sym022 every second week (Q2W) | 1.0 mg/kg dosing of Sym022 every second week (Q2W) | 3 mg/kg dosing of Sym022 every second week (Q2W) | 10.0 mg/kg dosing of Sym022 every second week (Q2W) | Total of all reporting groups |
| Overall Participants | 3 | 3 | 3 | 6 | 15 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
58
(10.82)
|
69
(1.73)
|
70.3
(13.28)
|
64.8
(6.11)
|
65.4
(8.69)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
1
33.3%
|
1
33.3%
|
1
33.3%
|
4
66.7%
|
7
46.7%
|
| Male |
2
66.7%
|
2
66.7%
|
2
66.7%
|
2
33.3%
|
8
53.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
3
100%
|
3
100%
|
2
66.7%
|
5
83.3%
|
13
86.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
1
33.3%
|
1
16.7%
|
2
13.3%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
1
6.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
1
6.7%
|
| White |
3
100%
|
3
100%
|
2
66.7%
|
4
66.7%
|
12
80%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
1
6.7%
|
| ECOG PS (Count of Participants) | |||||
| 0 |
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
1
6.7%
|
| 1 |
3
100%
|
3
100%
|
2
66.7%
|
6
100%
|
14
93.3%
|
Outcome Measures
| Title | Assessment of Treatment Related Adverse Events (AEs). |
|---|---|
| Description | Assess the safety, tolerability and dose-limiting toxicities of Sym022 on a Q2W schedule to establish the MTD and/or RP2D. |
| Time Frame | 19 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients evaluable for Maximum Tolerated Dose |
| Arm/Group Title | Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 |
|---|---|---|---|---|
| Arm/Group Description | 0.3 mg/kg dosing of Sym022 every second week (Q2W) | 1.0 mg/kg dosing of Sym022 every second week (Q2W) | 3 mg/kg dosing of Sym022 every second week (Q2W) | 10.0 mg/kg dosing of Sym022 every second week (Q2W) |
| Measure Participants | 3 | 3 | 3 | 6 |
| Number [Patients with any DLT] |
0
|
0
|
0
|
1
|
| Title | Evaluation of the Immunogenicity of Sym022. |
|---|---|
| Description | Serum sampling and incidence (%) per dose level to assess the potential for anti-drug antibody (ADA) formation. Count of participants show the number of participants who were tested positive for anti-Sym022 ADA. |
| Time Frame | 19 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 |
|---|---|---|---|---|
| Arm/Group Description | 0.3 mg/kg dosing of Sym022 every second week (Q2W) | 1.0 mg/kg dosing of Sym022 every second week (Q2W) | 3 mg/kg dosing of Sym022 every second week (Q2W) | 10.0 mg/kg dosing of Sym022 every second week (Q2W) |
| Measure Participants | 3 | 3 | 3 | 6 |
| Count of Participants [Participants] |
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Evaluation of Objective Response (OR) or Stable Disease (SD). |
|---|---|
| Description | Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), Response Evaluation Criteria in Lymphomas 2017 (RECIL 2017), or Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST), depending on tumor type. The numbers shown below correspond to the values related to RECIST v1.1. |
| Time Frame | 13 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 |
|---|---|---|---|---|
| Arm/Group Description | 0.3 mg/kg dosing of Sym022 every second week (Q2W) | 1.0 mg/kg dosing of Sym022 every second week (Q2W) | 3 mg/kg dosing of Sym022 every second week (Q2W) | 10.0 mg/kg dosing of Sym022 every second week (Q2W) |
| Measure Participants | 3 | 3 | 3 | 6 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
| Title | Time to Progression (TTP) of Disease. |
|---|---|
| Description | Based on time of enrollment to first evidence of progression on imaging studies, as assessed by RECIST v1.1, RECIL 2017, or iRECIST, depending on tumor type. The numbers shown below correspond to the values related to RECIST v1.1. |
| Time Frame | 13 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 |
|---|---|---|---|---|
| Arm/Group Description | 0.3 mg/kg dosing of Sym022 every second week (Q2W) | 1.0 mg/kg dosing of Sym022 every second week (Q2W) | 3 mg/kg dosing of Sym022 every second week (Q2W) | 10.0 mg/kg dosing of Sym022 every second week (Q2W) |
| Measure Participants | 3 | 3 | 3 | 6 |
| Median (95% Confidence Interval) [months] |
1.64
|
5.59
|
6.14
|
1.58
|
| Title | Area Under the Concentration-time Curve in a Dosing Interval (AUC). |
|---|---|
| Description | Will be estimated using non-compartmental methods and actual timepoints. |
| Time Frame | 19 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 |
|---|---|---|---|---|
| Arm/Group Description | 0.3 mg/kg dosing of Sym022 every second week (Q2W) | 1.0 mg/kg dosing of Sym022 every second week (Q2W) | 3 mg/kg dosing of Sym022 every second week (Q2W) | 10.0 mg/kg dosing of Sym022 every second week (Q2W) |
| Measure Participants | 3 | 3 | 3 | 6 |
| Mean (Standard Deviation) [hours*μg/mL] |
926
(151)
|
3860
(1010)
|
10000
(1720)
|
28300
(7110)
|
| Title | Maximum Concentration (Cmax) |
|---|---|
| Description | Will be derived from observed data. |
| Time Frame | 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 |
|---|---|---|---|---|
| Arm/Group Description | 0.3 mg/kg dosing of Sym022 every second week (Q2W) | 1.0 mg/kg dosing of Sym022 every second week (Q2W) | 3 mg/kg dosing of Sym022 every second week (Q2W) | 10.0 mg/kg dosing of Sym022 every second week (Q2W) |
| Measure Participants | 3 | 3 | 3 | 6 |
| Mean (Standard Deviation) [μg/mL] |
7.61
(1.706)
|
29.58
(4.060)
|
76.54
(4.865)
|
243.99
(88.517)
|
| Title | Time to Reach Maximum Concentration (Tmax) |
|---|---|
| Description | Will be derived from observed data. |
| Time Frame | 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 |
|---|---|---|---|---|
| Arm/Group Description | 0.3 mg/kg dosing of Sym022 every second week (Q2W) | 1.0 mg/kg dosing of Sym022 every second week (Q2W) | 3 mg/kg dosing of Sym022 every second week (Q2W) | 10.0 mg/kg dosing of Sym022 every second week (Q2W) |
| Measure Participants | 3 | 3 | 3 | 6 |
| Mean (Standard Deviation) [hours] |
3.06
(2.018)
|
4.52
(2.869)
|
2.43
(2.271)
|
1.98
(1.636)
|
| Title | Trough Concentration (Ctrough) |
|---|---|
| Description | Will be derived from observed data. |
| Time Frame | 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 |
|---|---|---|---|---|
| Arm/Group Description | 0.3 mg/kg dosing of Sym022 every second week (Q2W) | 1.0 mg/kg dosing of Sym022 every second week (Q2W) | 3 mg/kg dosing of Sym022 every second week (Q2W) | 10.0 mg/kg dosing of Sym022 every second week (Q2W) |
| Measure Participants | 3 | 3 | 3 | 6 |
| Mean (Standard Deviation) [μg/mL] |
0.85
(0.465)
|
4.09
(1.931)
|
12.22
(1.547)
|
44.10
(12.475)
|
| Title | Terminal Elimination Half-life (T½) |
|---|---|
| Description | Will be estimated using non-compartmental methods and actual timepoints. |
| Time Frame | 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week) |
Outcome Measure Data
| Analysis Population Description |
|---|
| For some participants in "Dose Level 4", the time span between the first and the last data point for the terminal rate constant did not cover at least 1.5 halflives, and these participants are therefore not part of the analysis. |
| Arm/Group Title | Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 |
|---|---|---|---|---|
| Arm/Group Description | 0.3 mg/kg dosing of Sym022 every second week (Q2W) | 1.0 mg/kg dosing of Sym022 every second week (Q2W) | 3 mg/kg dosing of Sym022 every second week (Q2W) | 10.0 mg/kg dosing of Sym022 every second week (Q2W) |
| Measure Participants | 3 | 3 | 3 | 3 |
| Mean (Standard Deviation) [hours] |
119.48
(33.674)
|
133.12
(35.491)
|
152.94
(24.570)
|
169.05
(18.830)
|
| Title | Clearance (CL) |
|---|---|
| Description | Will be estimated using non-compartmental methods and actual timepoints. |
| Time Frame | 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with an extrapolated AUC above 20% (for single dose administration) are not part of the analysis. |
| Arm/Group Title | Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 |
|---|---|---|---|---|
| Arm/Group Description | 0.3 mg/kg dosing of Sym022 every second week (Q2W) | 1.0 mg/kg dosing of Sym022 every second week (Q2W) | 3 mg/kg dosing of Sym022 every second week (Q2W) | 10.0 mg/kg dosing of Sym022 every second week (Q2W) |
| Measure Participants | 2 | 1 | 2 | 0 |
| Mean (Standard Deviation) [(mL/h)/kg] |
0.32
(0.006)
|
0.31
(NA)
|
0.24
(0.060)
|
Adverse Events
| Time Frame | From signing of informed consent through 30 days after last dose; through 2 months (or 4 months to 2 years) follow-up if related critical AEs persist | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Only treatment-emergent adverse events are presented in clinicaltrials.gov | |||||||
| Arm/Group Title | Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 | ||||
| Arm/Group Description | 0.3 mg/kg dosing of Sym022 every second week (Q2W) | 1.0 mg/kg dosing of Sym022 every second week (Q2W) | 3 mg/kg dosing of Sym022 every second week (Q2W) | 10.0 mg/kg dosing of Sym022 every second week (Q2W) | ||||
All Cause Mortality |
||||||||
| Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 5/6 (83.3%) | ||||
Serious Adverse Events |
||||||||
| Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 2/6 (33.3%) | ||||
| Gastrointestinal disorders | ||||||||
| Gastrointestinal haemorrhage | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| General disorders | ||||||||
| Chest Pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/6 (0%) | 0 |
| Infections and infestations | ||||||||
| Sepsis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Investigations | ||||||||
| Lipase increased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Tumour pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
| Dose Level 1 | Dose Level 2 | Dose Level 3 | Dose Level 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) | 6/6 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 2/6 (33.3%) | 4 |
| Eye disorders | ||||||||
| Lacrimation increased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Abdominal distension | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Abdominal pain | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 |
| Ascites | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Constipation | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 |
| Diarrhoea | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 2/6 (33.3%) | 2 |
| Dry mouth | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 |
| Nausea | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 |
| Vomiting | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 |
| General disorders | ||||||||
| Chest pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 |
| Chills | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 |
| Fatigue | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 3/6 (50%) | 3 |
| Influenza like illness | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 |
| Non-cardiac chest pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 2 |
| Swelling | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 |
| Hepatobiliary disorders | ||||||||
| Hepatic steatosis | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 |
| Portal vein thrombosis | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 |
| Infections and infestations | ||||||||
| Conjunctivitis viral | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 |
| Gastroenteritis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 |
| Otitis media | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Upper respiratory tract infection | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Fall | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 |
| Investigations | ||||||||
| Activated partial thromboplastin time prolonged | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 3 | 0/6 (0%) | 0 |
| Blood creatine phosphokinase increased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 |
| Lipase increased | 1/3 (33.3%) | 1 | 2/3 (66.7%) | 4 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 4 |
| N-terminal prohormone brain natriuretic peptide increased | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 |
| Dehydration | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Hypercalcaemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Hypomagnesaemia | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/6 (16.7%) | 2 |
| Hyponatraemia | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Hypophosphataemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 4 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Back pain | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Flank pain | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 |
| Nervous system disorders | ||||||||
| Dizziness | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 |
| Headache | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 |
| Psychiatric disorders | ||||||||
| Anxiety | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Depression | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Renal and urinary disorders | ||||||||
| Urinary tract obstruction | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 |
| Dyspnoea | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 |
| Pleural effusion | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||
| Dermatitis acneiform | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Hyperhidrosis | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 0/6 (0%) | 0 |
| Pruritus | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 |
| Umbilical discharge | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Symphogen AS |
| Phone | 004545265050 |
| info@symphogen.com |
- Sym022-01