Status:
COMPLETED
MGD009/MGA012 Combination in Relapsed/Refractory Cancer
Lead Sponsor:
MacroGenics
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of obrindatamab administered in combination with retifan...
Detailed Description
This study is a Phase 1, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary antitumor acti...
Eligibility Criteria
Inclusion
- Histologically-proven, unresectable locally advanced or metastatic solid tumors of any histology that test positive for B7-H3 expression on tumor cells or vasculature for whom no approved therapy with demonstrated clinical benefit is available. For all tumor types, the requirement for previous systemic therapy may be waived if a patient was intolerant of or refused standard first-line therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy ≥ 12 weeks
- Measurable disease, with the exception of prostate cancer
- Tissue specimen available for B7-H3 and PD-L1 expression testing
- Acceptable laboratory parameters
- Patients who have previously received an immune checkpoint inhibitor (e.g., anti- PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have toxicities related to the checkpoint inhibitor resolved to ≤ Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous hypothyroidism toxicity on a checkpoint inhibitor are eligible to enter study regardless of Grade resolution as long as the patient is well controlled on thyroid replacement hormones.
Exclusion
- Patients with history of prior central nervous system (CNS) metastasis must have been treated, must be asymptomatic, and must not have any of the following at the time of enrollment:
- No concurrent treatment for the CNS disease (e.g. surgery, radiation, corticosteroids \>10 mg prednisone/day or equivalent)
- 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
- Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing
- Treatment with any, investigational therapy within the 4 weeks prior to the initiation of study drug administration
- Treatment with any systemic chemotherapy within 3 weeks
- Treatment with radiation therapy within 2 weeks
- History of allogeneic bone marrow, stem-cell, or solid organ transplant
- Treatment with systemic corticosteroids (\> 10 mg per day prednisone or equivalent) or other immune suppressive drugs within 2 weeks
- Clinically significant cardiovascular or pulmonary disease
- Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug.
- Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
- Known 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
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03406949
Start Date
February 27 2018
End Date
April 27 2022
Last Update
May 19 2022
Active Locations (10)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
University of Southern California
Los Angeles, California, United States, 90033
3
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214