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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1. Participants in each cohort will receive zimberelimab intravenously Q3W. Treatment will continue until progressive disease, unacceptable toxicity, withdrawal of consent, or other reasons for which investigational product discontinuation occurs.
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
Objective response Rate (ORR)
Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Tumor assessments over time will be measured using RECIST v1.1
Time frame: Approximately 12 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Number of Participants Treated with zimberelimab with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Time frame: From screening until 90 days after the last dose of investigational product or until initiation of a new systemic anticancer therapy, whichever occurs first, approximately 12 months
Duration of response (DoR)
The time from first documentation of disease response (CR or PR) until first documentation of progressive disease.
Time frame: From the date of initiation of treatment until the date of first documented progression, through completion of the study, approximately 12 months
Time to response (TTR)
The time from treatment initiation to confirmed best overall response of CR or PR.
Time frame: From the date of initiation of treatment until the date of first documented response, through completion of the study, approximately 12 months
Disease control rate at 6 months (DCR6)
Number of Participants with Complete Response, Partial Response, or Stable Disease for Greater Than 6 Months per RECIST v1.1
Time frame: 6 Months
Progression-free survival at 6 (PFS6)
The percentage of Participants Without Disease Progression per RECIST v1.1 and iRECIST at 6 months
Time frame: 6 Months
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Kaiser Permanente Mid-Atlantic
Gaithersburg, Maryland, United States
Metro MN CCOP
Saint Louis Park, Minnesota, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
Saint Francis Cancer Center
Greenville, South Carolina, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Progression-free survival at 12 months (PFS12)
The percentage of Participants Without Disease Progression per RECIST v1.1 and iRECIST at 12 months
Time frame: 12 Months
Overall survival at 12 months (OS12)
The percentage of participants who are alive at 12 months based on first dose to date of death.
Time frame: 12 Months