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
Percentage 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)