Optimise viewing for

Toggle between patient and health professional views. The patient version is simplified to help people easily find suitable trials, while the professional view provides full detail.

RecruitingLast updated: 23 June 2026

This study is evaluating a new oral drug (called S095035) in adults with advanced or metastatic solid cancers with homozygous deletion of MTAPA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

This is a study of a targeted medicine called S095035 when given by itself, or in combination with another medicine called TNG462, in people with advanced or metastatic solid tumours.

You may be eligible if your locally advanced, unresectable, or metastatic solid cancer has a homozygous deletion of MTAP and have failed to respond to/have progressed following 1 prior treatment regimen.

 

Conditions

This trial is treating people with advanced or metastatic solid cancers 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.

Eligibility

Inclusion

  • Estimated life expectancy ≥3 months.
  • ECOG PS 0-1
  • Participants able to comply with highly effective method of birth control requirements.
  • Participants with histologically confirmed advanced or metastatic solid tumor's (excluding central nervous system tumors) that have progressed despite at least one prior treatment regimen given for advanced/metastatic disease, and for whom additional effective standard therapy is not available.
  • Participants with pre-existing documented MTAP homozygous deletion in their tumor tissue, determined using a next generation sequencing in vitro diagnostic test prior to screening.
  • Participants willing to undergo paired fresh biopsy (pre-treatment and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns.
  • Adequate organ functions.

Exclusion

  • Inability to take an orally administered drug, or medical disorder or prior surgical resection that may affect the absorption of the study drug.
  • Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's Medical monitor and investigator agree and document that it should not be exclusionary.
  • Known prior severe hypersensitivity to any component of the study drug formulation.
  • Major surgery within 4 weeks prior to the first IMP administration or participants who have not recovered from side effects of the surgery.
  • Have a known history of Gilbert's syndrome.
  • Participants with a known clinically significant cardiovascular disease or condition.
  • Participants with thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration.
  • Active brain metastases.
  • Current active liver or biliary disease.
  • Participants who have received systemic anticancer treatment or radiotherapy less than 2 weeks before the first dose of S095035. Participants who have not recovered from toxicity of previous anticancer therapy.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

This trial is operating as a teletrial at one or more locations. Learn more about teletrials.

Recruiting hospitals

+ Show non-recruiting hospitals

No longer recruiting (closed or complete) hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Servier Bio-Innovation LLC

Scientific Title

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

Get Support

Peer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Peer Connect

Contact cancer support

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.

Get support

Multilingual information

Learn more about clinical trials through this collection of resources in languages other than English.

View information