RECRUITING

Study of GS-5319 in Adults With Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-5319 in Adults With MTAP-deleted Advanced Solid Tumors

Quick Facts

Study Start:2025-08-28

Study Completion:2028-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07128303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 1. Part A and B: pretreatment tumor tissue is required	* 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

Inclusion Criteria

Exclusion 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:
1. Part A and B: pretreatment tumor tissue is required

* 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

Contacts and Locations

Study Contact

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0)

GileadClinicalTrials@gilead.com

Principal Investigator

Gilead Study Director

STUDY_DIRECTOR

Gilead Sciences

Study Locations (Sites)

START San Antonio

San Antonio, Texas, 78229

United States

NEXT Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Gilead Sciences

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-28

Study Completion Date2028-05

Study Record Updates

Study Start Date2025-08-28

Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor