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MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer

Sponsor
MacroGenics (Industry)
Overall Status
Completed
CT.gov ID
NCT03531632
Collaborator
(none)
38
Enrollment
6
Locations
1
Arm
20.2
Actual Duration (Months)
6.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary goal of this study is to characterize the safety, tolerability, and maximum tolerated dose (MTD) of MGD007 when combined with MGA012. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of the combination of MGD007 and MGA012 will also be assessed.

Condition or Disease Intervention/Treatment Phase
  • Biological: MGD007 + MGA012
 Phase 1/Phase 2

Detailed Description

This study is an open-label, Phase 1b/2, dose escalation and cohort expansion study designed to characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of MGD007 and MGA012, administered in combination by IV infusion, in patients with histologically proven, relapsed/refractory metastatic colorectal carcinoma, irrespective of the KRAS and MMR status of their tumors.

The study consists of a Dose Escalation Phase to determine the MTD or Maximum Administered Dose (MAD; if no MTD is defined) of the combination, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of the combination with the doses established in the Dose Escalation Phase.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b/2, Open Label, Dose Escalation Study of MGD007, a Humanized gpA33 × CD3 DART® Protein in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory Metastatic Colorectal Carcinoma
Actual Study Start Date :
Jun 4, 2018
Actual Primary Completion Date :
Feb 8, 2020
Actual Study Completion Date :
Feb 8, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: MGD007 + MGA012

MGD007 is a gpA33 x CD3 bi-specific DART antibody; MGA012 is an anti-PD-1 monoclonal antibody.

Biological: MGD007 + MGA012
MGD007 and MGA012 are administered by IV infusion.
Other Names:
  • MGA012 also known as INCMGA00012

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events [Up to approximately 12 weeks]

      Adverse Events, Serious Adverse Events

    Secondary Outcome Measures

    1. Peak Plasma Concentration [7 weeks]

      PK of MGD007 and MGA012 in combination

    2. Number of Participants That Develop Anti-drug Antibodies [1 year]

      Proportion of patients who develop anti-MGD007/MGA012 antibodies, immunogenicity

    3. The Number of Participants With Response Based on the Change in Tumor Volume [Every 8 weeks]

      Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and immune related RECIST criteria: number of patients with either complete response (CR) or partial response (PR) will determine the Overall Response Rate (ORR)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically proven, relapsed/refractory metastatic colorectal cancer

    • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

    • Measurable disease per RECIST 1.1 criteria

    • Participants in the Dose Escalation Phase must have had recurrence, progression or intolerance to standard therapy consisting of at least 2 prior standard regimens (containing a fluoropyrimidine plus a platinum analogue and/or irinotecan) for metastatic disease. Participants in the Cohort Expansion portion will be allowed to participate after 1 prior standard regimen. Those who are inappropriate candidates for or have refused treatment with these regimens are also eligible. No more than 5 prior therapies are permitted. Patients previously treated with MGD007 on Study Protocol CP-MGD007-01 and who did not develop antibodies to MGD007 while on the CP-MGD007-01 study, may be enrolled. Patients that were previously treated on CP-MGD007-01 will only be treated on this study once MTD/MAD has been defined.

    • Availability of sufficient tumor specimens to enable retrospective determination of gpA33, CD3, PD-1, and PD-L1 expression

    • 30 participants in the Cohort Expansion portion must have lesions that are accessible for paired biopsies with acceptable clinical risk in the judgment of the investigator.

    Exclusion Criteria:

    • Symptomatic central nervous system (CNS) metastases. No concurrent treatment for the CNS disease; no progression of CNS metastases on MRI or CT for at least 14 days after last day of prior therapy for the CNS metastases; no concurrent leptomeningeal disease or cord compression

    • History of known or suspected autoimmune disease with certain exceptions

    • History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation.

    • Major surgery, systemic anti-neoplastic therapy, or investigational therapy within 4 weeks

    • Radiation therapy within 2 weeks

    • Systemic corticosteroids (≥ 10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days

    • History of Grade 3 or greater drug-related diarrhea/colitis during treatment with checkpoint inhibitors including anti-LAG-3, anti-PD-1, anti PD-L1, or anti-CTLA-4 antibodies

    • Clinically significant cardiovascular disease; gastrointestinal disorders; pulmonary compromise; viral, bacterial, or systemic fungal infections

    • History of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome

    • History of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale School of Medicine New Haven Connecticut United States 06520
    2 Moffitt Cancer Center Tampa Florida United States 33612
    3 Massachusetts General Hospital Boston Massachusetts United States 02114
    4 University of Rochester Medical Center Rochester New York United States 14642
    5 Carolina Biooncology Institute Huntersville North Carolina United States 28078
    6 University of Washington Seattle Washington United States 98109

    Sponsors and Collaborators

    • MacroGenics

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    MacroGenics
    ClinicalTrials.gov Identifier:
    NCT03531632
    Other Study ID Numbers:
    • CP-MGD007-02
    First Posted:
    May 22, 2018
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    Participant Flow

    Recruitment Details Patients were recruited at 6 academic/oncology centers experienced in the conduct of clinical trials.
    Pre-assignment Detail
    Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3
    Arm/Group Description 0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks. 0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks. 0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
    Period Title: Overall Study
    STARTED 5 3 28
    Safety Population 5 3 28
    Response Evaluable Population 5 3 24
    COMPLETED 0 0 2
    NOT COMPLETED 5 3 26

    Baseline Characteristics

    Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3 Total
    Arm/Group Description 0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks. 0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks. 0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks. Total of all reporting groups
    Overall Participants 5 3 28 36
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    53.4
    (5.13)
    46.3
    (2.89)
    55.5
    (7.54)
    54.5
    (7.36)
    Sex: Female, Male (Count of Participants)
    Female
    3
    60%
    0
    0%
    13
    46.4%
    16
    44.4%
    Male
    2
    40%
    3
    100%
    15
    53.6%
    20
    55.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    1
    3.6%
    1
    2.8%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    1
    33.3%
    2
    7.1%
    3
    8.3%
    White
    5
    100%
    2
    66.7%
    25
    89.3%
    32
    88.9%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    5
    100%
    3
    100%
    28
    100%
    36
    100%
    ECOG Performance Status (Count of Participants)
    ECOG Performance Status 0 (Fully active without restriction)
    2
    40%
    1
    33.3%
    15
    53.6%
    18
    50%
    ECOG Performance Status 1 (restricted in physically strenuous activity, but ambulatory)
    3
    60%
    2
    66.7%
    13
    46.4%
    18
    50%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Adverse Events
    Description Adverse Events, Serious Adverse Events
    Time Frame Up to approximately 12 weeks

    Outcome Measure Data

    Analysis Population Description
    All patients who received at least one dose of study drug and reporting at least one adverse event
    Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3
    Arm/Group Description 0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks. 0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks. 0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
    Measure Participants 5 3 28
    Count of Participants [Participants]
    5
    100%
    3
    100%
    28
    100%
    2. Secondary Outcome
    Title Peak Plasma Concentration
    Description PK of MGD007 and MGA012 in combination
    Time Frame 7 weeks

    Outcome Measure Data

    Analysis Population Description
    PK assays were not performed since the Sponsor has decided not to continue clinical development of MGD007.
    Arm/Group Title MGD007 + MGA012
    Arm/Group Description MGD007 is a gpA33 x CD3 bi-specific DART antibody; MGA012 is an anti-PD-1 monoclonal antibody. MGD007 + MGA012: MGD007 and MGA012 are administered by IV infusion.
    Measure Participants 0
    3. Secondary Outcome
    Title Number of Participants That Develop Anti-drug Antibodies
    Description Proportion of patients who develop anti-MGD007/MGA012 antibodies, immunogenicity
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    ADA assays were not performed since the Sponsor has decided not to continue clinical development of MGD007.
    Arm/Group Title MGD007 + MGA012
    Arm/Group Description MGD007 is a gpA33 x CD3 bi-specific DART antibody; MGA012 is an anti-PD-1 monoclonal antibody. MGD007 + MGA012: MGD007 and MGA012 are administered by IV infusion.
    Measure Participants 0
    4. Secondary Outcome
    Title The Number of Participants With Response Based on the Change in Tumor Volume
    Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and immune related RECIST criteria: number of patients with either complete response (CR) or partial response (PR) will determine the Overall Response Rate (ORR)
    Time Frame Every 8 weeks

    Outcome Measure Data

    Analysis Population Description
    Response evaluable population
    Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3
    Arm/Group Description 0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks. 0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks. 0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
    Measure Participants 5 3 24
    Stable Disease
    0
    0%
    1
    33.3%
    10
    35.7%
    Progressive Disease
    5
    100%
    2
    66.7%
    14
    50%

    Adverse Events

    Time Frame Study Day 1 through study completion, average 36 days.
    Adverse Event Reporting Description Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
    Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3
    Arm/Group Description 0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks. 0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks. 0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
    All Cause Mortality
    Dose Level 1 Dose Level 2 Dose Level 3
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/5 (80%) 0/3 (0%) 14/28 (50%)
    Serious Adverse Events
    Dose Level 1 Dose Level 2 Dose Level 3
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/5 (20%) 1/3 (33.3%) 14/28 (50%)
    Cardiac disorders
    Acute coronary syndrome 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    Acute myocardial infarction 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    Sinus tachycardia 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    Gastrointestinal disorders
    Diarrhea 0/5 (0%) 0 0/3 (0%) 0 8/28 (28.6%) 8
    Vomiting 0/5 (0%) 0 0/3 (0%) 0 8/28 (28.6%) 8
    Nausea 0/5 (0%) 0 0/3 (0%) 0 4/28 (14.3%) 4
    Intussusception 0/5 (0%) 0 1/3 (33.3%) 1 0/28 (0%) 0
    Abdominal pain 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    Pancreatitis 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    General disorders
    Oedema peripheral 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Pyrexia 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Immune system disorders
    Cytokine release syndrome 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    Infections and infestations
    Biliary tract infection 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    Klebsiella sepsis 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    Liver abscess 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    Injury, poisoning and procedural complications
    Infusion related reaction 1/5 (20%) 1 0/3 (0%) 0 0/28 (0%) 0
    Renal and urinary disorders
    Renal colic 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    Pneumonitis 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    Pulmonary embolism 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    Vascular disorders
    Hypotension 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Embolism 0/5 (0%) 0 0/3 (0%) 0 1/28 (3.6%) 1
    Other (Not Including Serious) Adverse Events
    Dose Level 1 Dose Level 2 Dose Level 3
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/5 (100%) 3/3 (100%) 28/28 (100%)
    Blood and lymphatic system disorders
    Anaemia 0/5 (0%) 0 1/3 (33.3%) 1 7/28 (25%) 7
    Lymphopenia 3/5 (60%) 3 1/3 (33.3%) 1 1/28 (3.6%) 1
    Cardiac disorders
    Tachycardia 0/5 (0%) 0 1/3 (33.3%) 1 2/28 (7.1%) 2
    Sinus tachycardia 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Sinus bradycardia 1/5 (20%) 1 0/3 (0%) 0 0/28 (0%) 0
    Endocrine disorders
    Hypothyroidism 0/5 (0%) 0 1/3 (33.3%) 1 0/28 (0%) 0
    Gastrointestinal disorders
    Diarrhoea 1/5 (20%) 1 0/3 (0%) 0 24/28 (85.7%) 24
    Vomiting 0/5 (0%) 0 2/3 (66.7%) 2 23/28 (82.1%) 23
    Abdominal pain 5/5 (100%) 5 2/3 (66.7%) 2 16/28 (57.1%) 16
    Nausea 2/5 (40%) 2 1/3 (33.3%) 1 20/28 (71.4%) 20
    Abdominal distension 2/5 (40%) 2 1/3 (33.3%) 1 6/28 (21.4%) 6
    Constipation 1/5 (20%) 1 2/3 (66.7%) 2 5/28 (17.9%) 5
    Ascites 1/5 (20%) 1 0/3 (0%) 0 3/28 (10.7%) 3
    Abdominal pain upper 0/5 (0%) 0 0/3 (0%) 0 3/28 (10.7%) 3
    Flatulence 0/5 (0%) 0 0/3 (0%) 0 3/28 (10.7%) 3
    Gastritis 0/5 (0%) 0 1/3 (33.3%) 1 1/28 (3.6%) 1
    Haematochezia 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Proctitis 0/5 (0%) 0 1/3 (33.3%) 1 1/28 (3.6%) 1
    Intussusception 0/5 (0%) 0 1/3 (33.3%) 1 0/28 (0%) 0
    Proctalgia 0/5 (0%) 0 1/3 (33.3%) 1 0/28 (0%) 0
    General disorders
    Fatigue 1/5 (20%) 1 1/3 (33.3%) 1 16/28 (57.1%) 16
    Pyrexia 1/5 (20%) 1 1/3 (33.3%) 1 10/28 (35.7%) 10
    Oedema peripheral 2/5 (40%) 2 0/3 (0%) 0 7/28 (25%) 7
    Chills 0/5 (0%) 0 0/3 (0%) 0 6/28 (21.4%) 6
    Non-cardiac chest pain 0/5 (0%) 0 0/3 (0%) 0 3/28 (10.7%) 3
    Influenza like illness 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Injection site reaction 0/5 (0%) 0 1/3 (33.3%) 1 0/28 (0%) 0
    Cytokine release syndrome 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Infections and infestations
    Upper respiratory tract infection 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Urinary tract infection 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Injury, poisoning and procedural complications
    Infusion related reaction 2/5 (40%) 2 0/3 (0%) 0 0/28 (0%) 0
    Spinal compression fracture 1/5 (20%) 1 0/3 (0%) 0 0/28 (0%) 0
    Stoma site inflammation 1/5 (20%) 1 0/3 (0%) 0 0/28 (0%) 0
    Investigations
    Lymphocyte count decreased 1/5 (20%) 1 0/3 (0%) 0 7/28 (25%) 7
    Alanine aminotransferase increased 3/5 (60%) 3 0/3 (0%) 0 4/28 (14.3%) 4
    Aspartate aminotransferase increased 2/5 (40%) 2 0/3 (0%) 0 5/28 (17.9%) 5
    Blood bilirubin increased 2/5 (40%) 2 0/3 (0%) 0 2/28 (7.1%) 2
    Lipase increased 0/5 (0%) 0 0/3 (0%) 0 4/28 (14.3%) 4
    Activated partial thromboplastin time prolonged 0/5 (0%) 0 0/3 (0%) 0 3/28 (10.7%) 3
    Blood alkaline phophatase increased 1/5 (20%) 1 0/3 (0%) 0 2/28 (7.1%) 2
    Blood creatinine increased 1/5 (20%) 1 0/3 (0%) 0 2/28 (7.1%) 2
    Neutrophil count decreased 0/5 (0%) 0 0/3 (0%) 0 3/28 (10.7%) 3
    Weight decreased 0/5 (0%) 0 0/3 (0%) 0 3/28 (10.7%) 3
    International normalised ratio increased 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Blood fibrogen decreased 1/5 (20%) 1 0/3 (0%) 0 0/28 (0%) 0
    Lipase 0/5 (0%) 0 1/3 (33.3%) 1 0/28 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 1/5 (20%) 1 1/3 (33.3%) 1 8/28 (28.6%) 8
    Hypoalbuminaemia 1/5 (20%) 1 0/3 (0%) 0 7/28 (25%) 7
    Hypomagnesaemia 1/5 (20%) 1 0/3 (0%) 0 5/28 (17.9%) 5
    Hypophosphataemia 0/5 (0%) 0 0/3 (0%) 0 5/28 (17.9%) 5
    Dehydration 0/5 (0%) 0 1/3 (33.3%) 1 3/28 (10.7%) 3
    Hyperkalaemia 0/5 (0%) 0 1/3 (33.3%) 1 3/28 (10.7%) 3
    Hypocalcaemia 1/5 (20%) 1 0/3 (0%) 0 3/28 (10.7%) 3
    Hyponatraemia 0/5 (0%) 0 1/3 (33.3%) 1 3/28 (10.7%) 3
    Hypokalaemia 1/5 (20%) 1 0/3 (0%) 0 3/28 (10.7%) 3
    Hypermagnesaemia 1/5 (20%) 1 0/3 (0%) 0 1/28 (3.6%) 1
    Hyperglycaemia 1/5 (20%) 1 0/3 (0%) 0 0/28 (0%) 0
    Hyperuricaemia 1/5 (20%) 1 0/3 (0%) 0 0/28 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 0/5 (0%) 0 0/3 (0%) 0 5/28 (17.9%) 5
    Arthraligia 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Flank pain 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Muscle spasms 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Muscular weakness 1/5 (20%) 1 0/3 (0%) 0 0/28 (0%) 0
    Musculoskeletal chest pain 1/5 (20%) 1 0/3 (0%) 0 0/28 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour flare 2/5 (40%) 2 0/3 (0%) 0 2/28 (7.1%) 2
    Tumour pain 2/5 (40%) 2 1/3 (33.3%) 1 1/28 (3.6%) 1
    Nervous system disorders
    Headache 0/5 (0%) 0 0/3 (0%) 0 4/28 (14.3%) 4
    Paraesthesia 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Dizziness 0/5 (0%) 0 1/3 (33.3%) 1 0/28 (0%) 0
    Somnolence 1/5 (20%) 1 0/3 (0%) 0 0/28 (0%) 0
    Psychiatric disorders
    Insomnia 0/5 (0%) 0 0/3 (0%) 0 5/28 (17.9%) 5
    Anxiety 0/5 (0%) 0 0/3 (0%) 0 3/28 (10.7%) 3
    Agitation 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Depression 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Euphoric mood 1/5 (20%) 1 0/3 (0%) 0 0/28 (0%) 0
    Renal and urinary disorders
    Chromaturia 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Pollakiuria 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Reproductive system and breast disorders
    Vaginal haemorrhage 1/5 (20%) 1 0/3 (0%) 0 0/28 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/5 (0%) 0 0/3 (0%) 0 5/28 (17.9%) 5
    Productive cough 0/5 (0%) 0 0/3 (0%) 0 3/28 (10.7%) 3
    Cough 0/5 (0%) 0 1/3 (33.3%) 1 1/28 (3.6%) 1
    Haemoptysis 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Pneumonitis 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2
    Skin and subcutaneous tissue disorders
    Rash 0/5 (0%) 0 0/3 (0%) 0 4/28 (14.3%) 4
    Night sweats 1/5 (20%) 1 0/3 (0%) 0 0/28 (0%) 0
    Pruritis 0/5 (0%) 0 1/3 (33.3%) 1 0/28 (0%) 0
    Rash pruritic 0/5 (0%) 0 1/3 (33.3%) 1 0/28 (0%) 0
    Vascular disorders
    Hypertension 0/5 (0%) 0 1/3 (33.3%) 1 6/28 (21.4%) 6
    Hypotension 0/5 (0%) 0 0/3 (0%) 0 5/28 (17.9%) 5
    Flushing 1/5 (20%) 1 0/3 (0%) 0 2/28 (7.1%) 2
    Hot flush 0/5 (0%) 0 0/3 (0%) 0 2/28 (7.1%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Institution shall allow SPONSOR at least 45 days to review manuscript and at least 21 days to review poster, abstract or other material. SPONSOR can review publications solely for identifying Proprietary Information, which shall be removed upon SPONSOR's request to the extent deletion does not preclude complete/accurate presentation and interpretation of Study results; to identify patentable Inventions, and provide other comments, provided that Investigator isn't obligated to address comments.

    Results Point of Contact

    Name/Title Stephen Eck, M.D., Chief Medical Officer
    Organization MacroGenics, Inc.
    Phone 301 251-5172
    Email ecks@macrogenics.com
    Responsible Party:
    MacroGenics
    ClinicalTrials.gov Identifier:
    NCT03531632
    Other Study ID Numbers:
    • CP-MGD007-02
    First Posted:
    May 22, 2018
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022