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, and meet the age of majority/adulthood per local regulations. * 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 t…