Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
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.
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.
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
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