A Phase 1 Study to Evaluate the Safety and Tolerability of GS-2121 as Monotherapy and in Combination in Adults With Advanced Solid Tumors
Gilead Sciences
Summary
The main goal of this first-in-human (FIH) study is to learn about the safety and dosing of GS-2121 when given alone or in combination with zimberelimab (ZIM) in participants with advanced solid tumors. The primary objectives of this study are: * To assess the safety and tolerability of GS-2121 as monotherapy and GS-2121 in combination with zimberelimab in participants with advanced solid tumors. * To identify the maximum tolerated dose (MTD) / maximum administered dose (MAD) and/or the recommended phase 2 dose (RP2D) of GS-2121 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Participants diagnosed with histologically or cytologically confirmed advanced solid tumors who have progressed despite standard therapy, are intolerant to standard therapy, or are ineligible for standard therapy. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Tissue requirements: 1. Parts A-D: Pre-treatment tumor tissue is required. 2. Parts A and C backfill cohorts: Participants must agree to fresh pre- and on-treatment biopsies. * Adequate o…
Interventions
- DrugGS-2121
Tablet administered orally
- DrugZimberelimab
Administered intravenously
Locations (6)
- Stanford Cancer CenterPalo Alto, California
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- NEXT OncologySan Antonio, Texas
- NEXT VirginiaFairfax, Virginia
- The Ottawa Hospital Cancer CentreOttawa
- Princess Margaret Cancer CentreToronto