NCT06188702

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 342 (estimated)
• Sponsor: Servier Bio-Innovation LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-04-29
• Primary completion: 2031-10-31
• Completion: 2031-10-31
• First posted: 2024-01-03
• Last updated: 2026-04-03

Locations

35 sites across 8 countries: United States, Australia, Denmark, France, Germany, Italy, Japan, Spain

Regulatory

• FDA-regulated drug study