Study of GS-5319 in Adults With Solid Tumors

Gilead Sciences

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: GS-5319

Study type: Interventional

Funder types: Industry

Identifiers

NCT07128303

GS-US-707-7297

Details and patient eligibility

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).

Enrollment: 178 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

  1. Part A and B: 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

Part A: GS-5319 Monotherapy Dose Escalation

Experimental group

Description:

Participants will receive escalating doses of GS-5319 monotherapy, until disease progression, or until the participants meets other study drug discontinuation criteria as specified in protocol or up to 105 weeks, whichever occurs first to determine the recommended dose for dose expansion phase.

Treatment:

Drug: GS-5319

Part B: GS-5319 Monotherapy Dose Expansion

Experimental group

Description:

Participants will be enrolled in different cohorts based on the selected indications to receive GS-5319 monotherapy at the recommended dose during the monotherapy dose expansion phase.

Treatment:

Drug: GS-5319