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

NCT06188702 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

  • MTAP-deleted Solid Tumors

Interventions

DRUG

S095035

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

DRUG

TNG462

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

Sponsors & Collaborators

  • Institut de Recherches Internationales Servier

    collaborator OTHER

  • Tango Therapeutics, Inc.

    collaborator INDUSTRY

  • Servier Bio-Innovation LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2031-10-31
Completion
2031-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06188702 on ClinicalTrials.gov