Breast Cancer Clinical Trial

Safety Study of MGD009 in B7-H3-expressing Tumors

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.

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Full Description

This study is a Phase 1 open-label, dose escalation, cohort expansion, and efficacy follow-up study of MGD009 administered intravenously (IV) on an every-other-week schedule for up to one year (14 cycles).

The dose escalation phase is designed to characterize the safety and tolerability of MGD009 and to define the maximum tolerated or maximum administered dose (MTD/MAD). This phase will enroll patients with mesothelioma, bladder cancer, melanoma, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC), ovarian cancer, thyroid cancer, triple-negative breast cancer (TNBC), pancreatic cancer, colon cancer, soft tissue sarcoma, or prostate cancer.

In the cohort expansion phase, 6 cohorts of 16 patients each will be enrolled to further evaluate the safety and potential efficacy of MGD009 administered at the MTD/MAD dose in patients with mesothelioma, bladder cancer, melanoma, SCCHN, NSCLC, or other specific tumors that express high levels of B7-H3. Pre- and on-study biopsies are required for melanoma patients in the cohort expansion phase. Two additional cohorts (up to15 patients each) will evaluate the use of prophylaxis therapies to mitigate toxicity.

The survival follow-up phase consists of the 2-year period after the final dose of study drug.

All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

67

Study ID:

NCT02628535

Recruitment Status:

Terminated

Sponsor:

MacroGenics

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There are 20 Locations for this study

See Locations Near You

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 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, M5G1Z, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

67

Study ID:

NCT02628535

Recruitment Status:

Terminated

Sponsor:


MacroGenics

How clear is this clinincal trial information?

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