The goal of this clinical study is to learn more about the study drug, GS-5319, its dosing, safety and tolerability when given as a single medication and as a combined medication 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 as monotherapy and combination therapy in participants with MTAP-deleted advanced solid tumors and identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or the recommended dose(s) for expansion (RDE).
This study includes four arms, Parts A, B, C, and D. Participants in Parts A, B, and D are assigned non-randomized. Participants in Part C are assigned using a randomization procedure.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
476
Administered orally
Administered intravenously
Administered intravenously
Administered intravenously
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGSTART San Antonio
San Antonio, Texas, United States
RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
RECRUITINGYonsei University Severance Hospital
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
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
RECRUITING...and 1 more locations
Percentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs)
Time frame: Up to 2 years
Percentage of Participants Experiencing Laboratory Abnormalities
Time frame: Up to 2 years
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 2 years)
Pharmacokinetic (PK) parameter: AUC0-last of GS-5319
AUC0-last is the area under the concentration-versus-time curve from time 0 to the time of the last measurable (quantifiable) drug concentration.
Time frame: Predose and postdose up to end of treatment (up to 2 years)
Pharmacokinetic (PK) parameter: AUC0-inf of GS-5319
AUC0-inf is the area under the concentration-versus-time curve from time 0 extrapolated to infinite time, representing the total drug exposure after administration.
Time frame: Predose and postdose up to end of treatment (up to 2 years)
Pharmacokinetic (PK) parameter: AUCtau of GS-5319
AUCtau is defined as the area under the concentration-versus-time curve over one dosing interval at steady state.
Time frame: Predose and postdose up to end of treatment (up to 2 years)
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 2 years)
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 2 years)
Gilead Clinical Study Information Center
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