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Recruiting NCT07128303

Study of GS-5319 in Adults With Solid Tumors

Phase I Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GS-5319.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, South Korea, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug GS-5319
    Administered orally

Primary outcome measures

  • Percentage of Participants With Adverse Events (AEs) and Serous Adverse Events (SAEs) [Time frame: First Dose up to 30 days post last dose (Up to 105 weeks)]
  • Percentage of Participants Experiencing Laboratory Abnormalities [Time frame: First Dose up to 30 days post last dose (Up to 105 weeks)]
  • Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts [Time frame: Up to 21 days]
Secondary outcome measures (4)
  • Plasma Concentration of GS-5319 [Time frame: Predose and postdose up to end of treatment (up to 105 weeks)]
  • Pharmacokinetic (PK) parameter: AUC0-24 of GS-5319 [Time frame: Predose and postdose up to end of treatment (up to 105 weeks)]
  • PK parameter: Cmax of GS-5319 [Time frame: Predose and postdose up to end of treatment (up to 105 weeks)]
  • PK parameter: Tmax of GS-5319 [Time frame: Predose and postdose up to end of treatment (up to 105 weeks)]

Eligibility criteria

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:
  • Part A and B: pretreatment tumor tissue is required

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 4 centers
  • Yonsei University Severance Hospital — Seoul
  • Seoul National University Hospital — Seoul
  • Asan Medical Center — Seoul
  • Samsung Medical Center — Seoul
United States · 3 centers
  • Beth Israel Deaconess Medical Center — Boston
  • START San Antonio — San Antonio
  • NEXT Virginia — Fairfax
Spain · 3 centers
  • Vall d'Hebron Institute of Oncology (VHIO) — Barcelona
  • START Madrid - FJD - Hospital Fundación Jiménez Díaz - Phase I Clinical Trials Unit — Madrid
  • START - Centro Oncológico Clara Campal — Madrid

Identifiers

NCT: NCT07128303 · GS-US-707-7297

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗