GS-5319
DrugAdministered orally
NCT Number: NCT07128303
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Asan Medical Center, Seoul, South Korea
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.
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.
Administered orally
Administered intravenously
Administered intravenously
Administered intravenously
Time frame: Up to 2 years
Time frame: Up to 2 years
Time frame: Up to 21 days
Time frame: Predose and postdose up to end of treatment (up to 2 years)
Time frame: Predose and postdose up to end of treatment (up to 2 years)
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)
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)
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)
Cmax is defined the maximum observed plasma drug concentration.
Time frame: Predose and postdose up to end of treatment (up to 2 years)
Tmax is defined as the time to maximum observed concentration.
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-5319 Monotherapy and Combination Therapy in Adults With MTAP-deleted 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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