Spots Global Cancer Trial Database for MGD009/MGA012 Combination in Relapsed/Refractory Cancer
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Trial Identification
Brief Title: MGD009/MGA012 Combination in Relapsed/Refractory Cancer
Official Title: A Phase 1, Open Label, Dose Escalation Study of MGD009, a Humanized B7-H3 x CD3 DART® Protein, in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory B7-H3-Expressing Tumors
Study ID: NCT03406949
Conditions
Study Description
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 retifanlimab in patients with B7-H3- expressing tumors.
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 activity of the combination of obrindatamab and retifanlimab, each of which is administered by IV infusion. The study consists of a Dose Escalation Phase to determine the Maximum Tolerated Dose (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. Patients with B7-H3-expressing unresectable, locally advanced, or metastatic solid tumors of any histology will be enrolled in the Dose Escalation Phase. Following the establishment of an MTD, additional patients with specific tumor types will enroll in the Cohort Expansion Phase.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Medical Center, Duarte, California, United States
University of Southern California, Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
START (South Texas Accelerated Research Therapeutics) - Midwest, Grand Rapids, Michigan, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Mary Crowley Cancer Center, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Contact Details
Name: Stephen L Eck, M.D.
Affiliation: MacroGenics
Role: STUDY_DIRECTOR
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