Actively Recruiting
Study of GS-5319 in Adults With Solid Tumors
Led by Gilead Sciences · Updated on 2026-03-19
178
Participants Needed
8
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of GS-5319 in Adults With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with a confirmed solid tumor type that has progressed despite or is intolerant to standard therapy or is ineligible for standard therapy in advanced setting (locally advanced or metastatic)
- Tumor is deficient in methylthioadenosine phosphorylase (MTAP) enzyme confirmed by DNA sequencing or central lab assay
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
- Adequate organ function
- Age 18 years or older (19 years or older for patients in South Korea)
- Pretreatment tumor tissue available for parts A and B of the study
You will not qualify if you...
- Active second malignancy unless completely treated with no active cancer evidence for 3 years or surgically cured tumor with low recurrence risk
- Positive pregnancy test or currently breastfeeding
- Need for ongoing therapy with prohibited medications
- Not recovered from adverse events due to previous treatments
- Active, uncontrolled infections requiring systemic antibiotics, antifungals, or antivirals
- Symptomatic ascites or pleural effusion requiring medical intervention
- Active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
3
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
4
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
5
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
6
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain, 08035
Actively Recruiting
7
START Madrid - FJD - Hospital Fundación Jiménez Díaz - Phase I Clinical Trials Unit
Madrid, Spain, 28040
Actively Recruiting
8
START - Centro Oncológico Clara Campal
Madrid, Spain, 28050
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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