RecruitingPhase 1Phase 2NCT06188702

S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP

A Phase 1/2, Open-label, Multicenter Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Antineoplastic Activity of S095035 (MAT2A Inhibitor) as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Homozygous Deletion of MTAP

Sponsor

Servier Bio-Innovation LLC

Enrollment

342 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

MTAP-deleted Solid Tumors

Summary

This is a first-in-human Phase 1/2, multicenter, open-label study of S095035 as single-agent, or in combination with TNG462 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have failed to respond to or have progressed after at least 1 prior treatment regimen, and for whom additional effective standard treatment is not available. S095035 is an oral methionine adenosyltransferase 2A \[MAT2A\] inhibitor. TNG462 is a protein arginine N-methyltransferase 5 \[PRMT5\] inhibitor.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This first-in-human study tests a new drug called S095035 — alone or in combination — in adults with advanced or metastatic solid tumors that have a specific genetic deletion called MTAP deletion. This genetic change makes cancer cells potentially vulnerable to certain new drugs. **You may be eligible if...** - You have a confirmed advanced or metastatic solid tumor (excluding most brain tumors, except IDH-wildtype glioblastoma) - Your tumor has a confirmed MTAP deletion - Your disease is measurable on imaging - You are in good health (ECOG performance status 0–1) - Your life expectancy is at least 3 months **You may NOT be eligible if...** - Your tumor does not have the MTAP deletion - You have most types of brain tumors (except IDH-wildtype glioblastoma) - You have uncontrolled infections or serious organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGS095035

S095035 will be taken orally every day in 28-day cycles.

DRUGTNG462

TNG462 will be taken orally every day in 28-day cycles.

Locations(35)

University of California Los Angeles

Los Angeles, California, United States

University of California, San Francisco (Ucsf) School of Medicine

San Francisco, California, United States

Lake Mary Cancer Center - Florida Cancer Specialists & Research Institute

Lake Mary, Florida, United States

Community Health Network

Indianapolis, Indiana, United States

Dana Farber Cancer Institue

Boston, Massachusetts, United States

Duke University School of Medicine

Durham, North Carolina, United States

Taylor Cancer Research Center

Maumee, Ohio, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

NEXT Oncology

Austin, Texas, United States

Scientia Clinical Research

Randwick, New South Wales, Australia

The Alfred

Prahran, Victoria, Australia

Townsville University Hospital

Douglas, Australia

Royal Hobart Hospital

Hobart, Australia

University Hospital Rigshospitalet

Copenhagen, Denmark

Odense Universitets Hospital

Odense, Denmark

Institut Bergonié

Bordeaux, France

Centre Georges-François Leclerc

Dijon, France

Hôpital de la Timone (Marseille)

Marseille, France

Institut Gustave Roussy

Paris, France

Charite Universitatsmedizin

Berlin, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Med Fakultaet Heidelberg

Heidelberg, Germany

Universitätsklinikum Ulm

Ulm, Germany

Istituto Europeo Di Oncologia

Milan, Italy

A.O.U. Seconda Università Degli Studi Di Napoli

Naples, Italy

Ist. Nazionale Tumori Irccs Fondazione G Pascale

Naples, Italy

Instituto Clinico Humanitas Irccs

Rozzano, Italy

Policlinico G.B. Rossi A.O.U.I. Di Verona

Verona, Italy

Aichi Cancer Center

Aichi, Japan

National Hospital Organization Shikoku Cancer Center

Ehime, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Next Oncology-Hospital Quironsalud Barcelona

Barcelona, Spain

Hospital Vall D'Hebron

Barcelona, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Start Madrid Group - Hm Ciocc

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT06188702

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