Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors
NCT Number: NCT06532565
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumors
Interventions: DRUG: GS-2121|DRUG: Zimberelimab
Sponsor: Gilead Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 154
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-26
Completion Date: 2028-06
Locations: NEXT Oncology, San Antonio, Texas, 78229, United States|NEXT Virginia, Fairfax, Virginia, 22031, United States

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.

Primary Outcome Measures: Parts A and B: Percentage of Participants with Adverse Events and Serious Adverse Events, First dose up to 90 days post last dose (up to approximately 118 weeks)|Parts A and B: Percentage of Participants with Laboratory Abnormalities, 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., Day 1 up to Day 21|Parts C and D: Percentage of Participants with Adverse Events and Serious Adverse Events, First dose up to 90 days post last dose (up to approximately 118 weeks)|Parts C and D: Percentage of Participants with Laboratory Abnormalities, 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., Day 1 up to Day 21
Secondary Outcome Measures: Parts A and B: Plasma Concentration of GS-2121 and Active Metabolite, Predose and postdose up to end of treatment (up to 105 weeks)|Parts A and B: PK Parameter: AUC0-24 of GS-2121, AUC0-24 is defined as the partial area under the concentration of drug over time between time 0 and time 24 hours. PK parameters will be estimated as applicable, based on the availability of data., Predose and postdose up to end of treatment (up to 105 weeks)|Parts A and B: PK Parameter: Cmax of GS-2121, Cmax is defined as the maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data., Predose and postdose up to end of treatment (up to 105 weeks)|Parts A and B: PK Parameter: Tmax of GS-2121, Tmax is defined as the time to maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data., Predose and postdose up to end of treatment (up to 105 weeks)|Parts C and D: Plasma Concentration of GS-2121 and Active Metabolite, Predose and postdose up to end of treatment (up to 105 weeks)|Parts C and D: PK Parameter: AUC0-24 of GS-2121, AUC0-24 is defined as the partial area under the concentration of drug over time between time 0 and time 24 hours. PK parameters will be estimated as applicable, based on the availability of data., Predose and postdose up to end of treatment (up to 105 weeks)|Parts C and D: PK Parameter: Cmax of GS-2121, Cmax is defined as the maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data., Predose and postdose up to end of treatment (up to 105 weeks)|Parts C and D: PK Parameter: Tmax of GS-2121, Tmax is defined as the time to maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data., Predose and postdose up to end of treatment (up to 105 weeks)