A Phase 1 Study to Evaluate the Safety and Tolerability of GS-0201 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-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors. The primary objectives of this study are to: * To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors * To identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and/or the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected advanced solid tumors
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Able to understand and give written informed consent. * Assigned female or male at birth, 18 years of age or older. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria by investigator assessment. * Organ function requirements: * Adequate hematologic function * Adequate hepatic function * Creatinine clearance * Coagulation * Tissue requirement: * Parts A, B, C, and D: * Pre-treatment tumor tissue is required. * Parts A and C backfill biopsy coh…
Interventions
- DrugGS-0201
Pill administered orally
- DrugSacituzumab Govitecan
Administered intravenously
Locations (7)
- Dana-Farber Cancer InstituteBoston, Massachusetts
- NEXT AustinAustin, Texas
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- NEXT DallasIrving, Texas
- Rambam Health Care CampusHaifa
- Tel Aviv Sourasky Medical CenterTel Aviv