The goal of this clinical study is to learn more about the study drug, GS-5319, its dosing, safety and tolerability in adults with solid tumors, where the participants show a specific gene alteration in the tumor. The gene helps produce methylthioadenosine phosphorylase (MTAP) enzyme. MTAP enzyme helps in normal growth of cells. The primary objectives of the study are to assess the safety and tolerability of GS-5319 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors and to identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or the recommended dose for expansion (RDE).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
Administered orally
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGSTART San Antonio
San Antonio, Texas, United States
RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGVall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain
RECRUITINGSTART Madrid - FJD - Hospital Fundación Jiménez Díaz - Phase I Clinical Trials Unit
Madrid, Spain
RECRUITINGPercentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs)
Time frame: First Dose up to 30 days post last dose (Up to 105 weeks)
Percentage of Participants Experiencing 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) in Dose-escalation Cohorts
Time frame: Up to 21 days
Plasma Concentration of GS-5319
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Pharmacokinetic (PK) parameter: AUC0-24 of GS-5319
AUC0-24 is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
PK parameter: Cmax of GS-5319
Cmax is defined the maximum observed plasma drug concentration.
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
PK parameter: Tmax of GS-5319
Tmax is defined as the time to maximum observed concentration.
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Gilead Clinical Study Information Center
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