S095035 in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene

• Status: Recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a first-in-human Phase 1, multicenter, open-label dose escalation study of S095035 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Servier Bio-Innovation LLC
• Collaborator: Institut de Recherches Internationales Servier

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.