GS-2121
DrugTablet administered orally
NCT Number: NCT06532565
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
The Ottawa Hospital Cancer Centre, Ottawa, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Tablet administered orally
Administered intravenously
Other names: GS-0122, AB122
Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)
Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)
Time frame: Day 1 up to Day 21
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: First dose up to 90 days post last dose (up to approximately 118 weeks)
Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)
Time frame: Day 1 up to Day 21
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: Predose and postdose up to end of treatment (up to 105 weeks)
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
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.
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Cmax is defined as the maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Tmax is defined as the time to maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
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.
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Cmax is defined as the maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Tmax is defined as the time to maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.
Contact information is provided by the study sponsor or research team.
Gilead Sciences
Industry
A Phase 1 Study to Evaluate the Safety and Tolerability of GS-2121 as Monotherapy and in Combination in Adults With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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