A Phase 1 Study to Evaluate the Safety and Tolerability of GS-2121 as Monotherapy and in Combination in Adults With Advanced Solid Tumors
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.
Arms & interventions
- DrugGS-2121
Tablet administered orally
- DrugZimberelimab
Administered intravenously
Outcome measures
Primary
Parts A and B: Percentage of Participants with Adverse Events and Serious Adverse Events
Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)
Parts A and B: Percentage of Participants with Laboratory Abnormalities
Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)
Part A: Percentage of Participants with Dose-Limiting Toxicities (DLTs) During Dose Escalation
DLTs are defined as any of the protocol-specified treatment-emergent adverse events (AEs) with onset within the DLT-evaluation period for the corresponding dose.
Time frame: Day 1 up to Day 21
Parts C and D: Percentage of Participants with Adverse Events and Serious Adverse Events
Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)
Parts C and D: Percentage of Participants with Laboratory Abnormalities
Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)
Part C: Percentage of Participants with DLTs During Dose Escalation
DLTs are defined as any of the protocol-specified treatment-emergent adverse events (AEs) with onset within the DLT-evaluation period for the corresponding dose.
Time frame: Day 1 up to Day 21
Secondary
Parts A and B: Plasma Concentration of GS-2121 and Active Metabolite
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts A and B: PK Parameter: AUC0-24 of GS-2121
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts A and B: PK Parameter: Cmax of GS-2121
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts A and B: PK Parameter: Tmax of GS-2121
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts C and D: Plasma Concentration of GS-2121 and Active Metabolite
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts C and D: PK Parameter: AUC0-24 of GS-2121
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts C and D: PK Parameter: Cmax of GS-2121
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts C and D: PK Parameter: Tmax of GS-2121
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Eligibility criteria
Study locations (4)
Stanford Cancer Center
Palo Alto, California, 94305
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
NEXT Oncology
San Antonio, Texas, 78229
NEXT Virginia
Fairfax, Virginia, 22031