The goal of this clinical study is to learn more about the study drug GS-2426, and how safe and tolerable it is in participants with advanced methylthioadenosine phosphorylase (MTAP)-deleted solid tumors. The primary objective of this study is to evaluate the safety and tolerability of GS-2426 in participants with MTAP-deleted advanced solid tumors and to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended phase II dose (RP2D).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Administered Orally
START Midwest
Grand Rapids, Michigan, United States
RECRUITINGSTART Astera, LLC
East Brunswick, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGPercentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE)
Time frame: First dose up to 30 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time frame: First dose up to 30 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing Any Dose-limiting Toxicities (DLTs)
Time frame: First dose up to 21 days post first dose
Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD)
Time frame: First dose up to 21 days post first dose
Recommended Phase 2 Dose (RP2D)
Time frame: Predose to end of study (up to 105 weeks)
Plasma Concentration of GS-2426
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Pharmacokinetic (PK) Parameter: AUC0-24h of GS-2426
AUC0-24h is defined as the area under concentration versus time from 0 to 24 hours.
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameters: Cmax of GS-2426
Cmax is defined as the maximum observed plasma drug concentration.
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameters: Tmax of GS-2426
Tmax is defined as the time to peak plasma drug concentration of GS-2426.
Gilead Clinical Study Information Center
CONTACT
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START San Antonio, LLC
San Antonio, Texas, United States
RECRUITINGTime frame: Predose and postdose up to end of treatment (up to 105 weeks)