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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
* Participants diagnosed with histologically or cytologically confirmed solid tumor types who have progressed despite standard therapy, are intolerant to standard therapy, or are ineligible for standard therapy in the advanced setting (locally-advanced or metastatic).
* Participant tumors are methylthioadenosine phosphorylase (MTAP)-deficient. Deoxyribonucleic acid (DNA) sequencing may be assessed locally such as by local next-generation sequencing (NGS) or by central laboratory assay when available.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
* Adequate organ function
* Age ≥ 18yrs old ( ≥ 19 years old for patients in South Korea)
* Participants must meet the following tissue requirements:
* pretreatment tumor tissue is required
Key Exclusion Criteria:
* Active second malignancy. Participants with a history of malignancy who have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or participants with surgically cured tumors with low risk of recurrence may be enrolled.
* Positive serum pregnancy test or participant who is breastfeeding.
* Requirement for ongoing therapy with any prohibited medications.
* Have not recovered (ie, returned to Grade 1 or baseline) from adverse events (AEs) due to a previously administered agent.
* Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.
* Ascites or pleural effusion that is symptomatic and/or requiring medical intervention.
* Active human immunodeficiency virus (HIV)/hepatitis B virus (HBV)/hepatitis C virus (HCV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary outcome measure(s)
Percentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs) — Up to 2 years
Percentage of Participants Experiencing Laboratory Abnormalities — Up to 2 years
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts — Up to 21 days
Trial sites (11)
Facility
City
Region
Status
Massachusetts General Hospital
Boston
Massachusetts
Recruiting
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Recruiting
START San Antonio
San Antonio
Texas
Recruiting
NEXT Virginia
Fairfax
Virginia
Recruiting
Yonsei University Severance Hospital
Seoul
South Korea
Recruiting
Seoul National University Hospital
Seoul
South Korea
Recruiting
Asan Medical Center
Seoul
South Korea
Recruiting
Samsung Medical Center
Seoul
South Korea
Recruiting
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona
Spain
Recruiting
START Madrid - FJD - Hospital Fundación Jiménez Díaz - Phase I Clinical Trials Unit
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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