A Phase 1b Study to Evaluate the Safety and Clinical Activity of AB122 in Biomarker-Selected Participants With Advanced Solid Tumors
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.
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.
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Capable of giving signed informed consent;
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Male or female participants = > 18 years of age at the time of screening;
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Negative serum pregnancy test at screening and negative serum or urine pregnancy test every 3 months during the treatment period (women of childbearing potential only);
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Pathologically confirmed tumor that is metastatic, advanced, or recurrent with progression for which no alternative or curative therapy exists. Tumors must be TMB-H or Strata Immune Signature positive;
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Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The measurable lesion must be outside of a radiation field if the participant received prior radiation;
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
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Please contact study team for more eligibility criteria;
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Use of any live attenuated vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product;
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Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational product hazardous or obscure the interpretation of toxicity determination or AEs;
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History of myocardial infarction within 6 months or history of arterial thromboembolic event within 3 months of the first dose of investigational agent;
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Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
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Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 90 days after the last dose of investigational product;
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Please contact study team for more eligibility criteria;
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