Study Stopped
Business decision (not for safety reasons)
Safety Study of MGD009 in B7-H3-expressing Tumors
Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients With Unresectable or Metastatic B7-H3-Expressing Neoplasms
1 other identifier
interventional
67
3 countries
20
Brief Summary
The purpose of this study is to evaluate the safety of MGD009 when given to patients with B7-H3-expressing tumors. The study will also evaluate what is the highest dose of MGD009 that can be given safely. Assessments will be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate potential anti-tumor activity of MGD009.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2015
Longer than P75 for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 20, 2015
CompletedFirst Posted
Study publicly available on registry
December 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2019
CompletedFebruary 8, 2022
February 1, 2022
4.2 years
November 20, 2015
February 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events
adverse events, serious adverse events
28 days after last dose of study drug
Secondary Outcomes (3)
Peak plasma concentration
8 days
Number of participants that develop anti-drug antibodies
first dose through 28 days after last dose of study drug
Change in tumor volume
Weeks 6, 15, 24, 33, 42, 51, 60, 69, 78, 87, 96, 105
Study Arms (1)
MGD009
EXPERIMENTALOrlotamab; Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART®) Protein
Interventions
Eligibility Criteria
You may qualify if:
- Histologically and/or cytologically proven unresectable locally advanced or metastatic tumors that express B7-H3 on the membrane or vasculature. The requirement for previous systemic therapy may be waived if a person was intolerant of standard front-line therapy
- Dose escalation phase prior systemic treatment requirements:
- pleural mesothelioma, pancreatic cancer: 1-3 prior treatments
- urothelial, SCHNN, prostate, soft tissue sarcoma, prostate cancer, TNBC, ccRCC, NSCLC: 1-5 prior treatments
- ovarian cancer: 2-4 prior treatments
- colon cancer: 2-4 prior treatments
- cutaneous melanoma: at least 1 prior treatment (including immunotherapy).
- Patients with prior immune checkpoint inhibitors must have related toxicities reduced to Grade 0, 1, or baseline
- Measurable disease per RECIST 1.1 criteria
- Easter Cooperative Oncology Group (ECOG) performance status 0 or 1
- Acceptable laboratory parameters and adequate organ reserve.
You may not qualify if:
- Patients with central nervous system (CNS) involvement must have been treated, be asymptomatic, do not exhibit progression of CNS metastases on MRI or CT within 28 days, and do not have concurrent leptomeningeal disease or cord compression.
- Clinically significant pulmonary compromise within 28 days of first dose, including pneumonia, pneumonitis, requirement for supplemental oxygen). use to maintain adequate oxygenation, or pleural effusion sufficient to warrant pleurocentesis or any history of ≥ Grade 3 drug induced or radiation pneumonitis.
- History of autoimmune disease with certain exceptions such as vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic therapy within the past 2 years, patients with history of Hashimoto's or Grave's disease that are now euthyroid clinically and by lab testing
- History of clinically-significant cardiovascular disease, or cardiac arrhythmias, including atrial fibrillation at screening or day of treatment
- History of clinically-significant gastrointestinal (GI) disease; GI perforation within 1 year; GI bleeding or acute pancreatitis within 3 months; or diverticulitis within 4 weeks of first study drug administration
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days of first study drug administration
- Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction (PCR)
- Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
- History of allogeneic bone marrow, stem cell, or solid organ transplant
- Treatment with systemic cancer therapy or investigational therapy within 3 weeks of first study drug administration; radiation within 2 weeks; corticosteroids (greater than or equal to 10 mg prednisone or equivalent per day) or other immune suppressive drugs within 2 weeks of first study drug administration
- Trauma or major surgery within 4 weeks of first study drug administration
- Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for MGD009
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MacroGenicslead
Study Sites (20)
UCLA
Los Angeles, California, 90095, United States
Stanford University School of Medicine
Palo Alto, California, 94304, United States
University of California - San Francisco
San Francisco, California, 94143, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
New York University
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Henry-Joyce Cancer Center
Nashville, Tennessee, 37232, United States
Mary Crowley Cancer Research Center
Dallas, Texas, 75230, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22034, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Saint Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Linear Clinical Research
Nedlands, Western Australia, 6009, Australia
Princess Margaret Cancer Centre
Toronto, Ontario, M5G1Z5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2015
First Posted
December 11, 2015
Study Start
September 1, 2015
Primary Completion
November 25, 2019
Study Completion
November 25, 2019
Last Updated
February 8, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share