Spots Global Cancer Trial Database for Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors
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Trial Identification
Brief Title: Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors
Official Title: A Phase 1b Study to Evaluate the Safety and Clinical Activity of AB122 in Biomarker-Selected Participants With Advanced Solid Tumors
Study ID: NCT04087018
Conditions
Interventions
Study Description
Brief Summary: This is a Phase 1b open-label study to evaluate the safety and clinical activity of zimberelimab (AB122) in biomarker-selected participants with advanced solid tumors.
Detailed Description: The activity of zimberelimab every 3 weeks (Q3W) will be evaluated in molecularly defined patient populations as described by the StrataNGS test (to be performed outside of this study protocol). Participants with any advanced tumor type will be stratified evenly by tumor biomarker status as follows: TMB-H or Strata Immune Signature positive. Each cohort may enroll approximately 40 participants. Following completion of and/or discontinuation from investigational product and follow-up, all participants will be followed for survival.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Southern California Permanente Medical Group, Riverside, California, United States
Kaiser Permanente (NorCal) - Roseville, Roseville, California, United States
Christiana Care Health System - Helen F. Graham Cancer Center, Newark, Delaware, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Kaiser Permanente Mid-Atlantic, Gaithersburg, Maryland, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Lehigh Valley Health Newtown - Cedar Crest, Allentown, Pennsylvania, United States
Institute for Translational Oncology Research (Prisma Health), Greenville, South Carolina, United States
St. Francis Cancer Center, Greenville, South Carolina, United States
Gunderson Lutheran Medical Center, La Crosse, Wisconsin, United States
University of Wisconsin Hospitals and Clinicals, Madison, Wisconsin, United States
Contact Details
Name: Medical Director
Affiliation: Arcus Biosciences, Inc.
Role: STUDY_DIRECTOR
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