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Study of S095035 and TNG462 in adults with advanced or metastatic solid tumors with MTAP deletion

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial investigates two medications - TNG462 and S095035 - for treating patients with advanced or metastatic solid tumors that have a specific genetic characteristic called MTAP deletion. Both medications are taken by mouth in the form of tablets. The purpose of this study is to evaluate how safe these medications are when used alone or in combination, and to determine their effectiveness in treating these types of cancers.

The study consists of two parts. The first phase aims to find the right dose of the medications and assess their safety. The second phase focuses on determining how well the treatments work in fighting the cancer. The types of cancer being studied include non-small cell lung cancer, biliary tract cancer, pancreatic cancer, gastroesophageal cancer, and glioblastoma (a type of brain tumor), as long as they have the specific MTAP genetic characteristic.

During the study, participants will receive either S095035 alone or in combination with TNG462. The researchers will monitor how the medications affect the tumors and track any side effects that may occur. They will also study how the medications are processed by the body and measure various aspects of the treatment's effectiveness, such as how long it takes for tumors to respond and how long the response lasts.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial phase determination

    You will be assigned to either Phase 1 or Phase 2 of the study based on your medical condition and eligibility criteria.

    Your tumor tissue will be tested for MTAP gene deletion using specialized diagnostic testing.

  2. Step 2

    Treatment assignment

    You will receive either S095035 alone or in combination with TNG462.

    Both medications are taken orally in tablet form.

    The specific dosage will be determined based on your assigned study phase and treatment group.

  3. Step 3

    Tumor tissue collection

    If you are in Phase 1 or Phase 2 (except for brain tumor patients), a tumor tissue sample will be collected before starting treatment.

    For patients with brain tumors, previous tissue samples from recent surgery may be used.

  4. Step 4

    Treatment monitoring

    Regular health assessments will include physical examinations, vital signs, and heart monitoring (ECG).

    Blood tests will be conducted to monitor your body's response to treatment.

    Your ability to perform daily activities will be evaluated using a performance status scale (ECOG).

  5. Step 5

    Treatment effectiveness evaluation

    Your tumor response to treatment will be measured using specialized criteria (RECIST or RANO).

    Regular scans will be performed to monitor changes in tumor size.

    Independent experts will review your scan results to assess treatment effectiveness.

  6. Step 6

    Side effect monitoring

    Any side effects or health changes will be tracked throughout the study.

    The study team will monitor for both mild and serious side effects.

    Medication doses may be adjusted if needed based on side effects.

Who can join the trial?

13 criteria

  • Must be at least 18 years old
  • Must have adequate organ function to participate in the study
  • Must have a life expectancy of 3 months or longer
  • Must have good physical function status (ECOG score of 0-1, meaning able to perform daily activities with minimal assistance)
  • Must be able to follow strict birth control requirements
  • Must have an advanced or spreading solid tumor that has been confirmed through tissue examination (except for certain brain tumors)
  • Must have a tumor that has gotten worse after at least one previous treatment for advanced disease
  • Must have a confirmed MTAP gene deletion in tumor tissue (determined by genetic testing before screening)
  • For Phase 1 participants: Must be willing to provide tumor tissue samples before and during treatment (unless medically unsafe)
  • For Phase 2 participants with brain tumors (IDHwt glioblastoma): Must provide tissue from most recent surgery or biopsy
  • For Phase 2 participants (except brain tumors): Must provide new tumor tissue samples during screening, unless not safe to do so or if a tissue sample was taken within the last 3 months without any treatment since then
  • Must have tumors that can be measured using standard imaging criteria (RECIST 1.1 or RANO 2.0 for brain tumors)
  • Must have no other standard treatment options available that would be beneficial

Who cannot join the trial?

15 criteria

  • History of severe allergic reactions to medications
  • Active brain metastases (cancer that has spread to the brain) that are not treated or stable
  • Significant heart conditions including heart failure, unstable angina, or recent heart attack within the last 6 months
  • Active or chronic hepatitis B or C infection (liver infections)
  • HIV infection that is not well-controlled with medication
  • Other active cancers requiring treatment (except for certain skin cancers or in situ cervical cancer)
  • Major surgery within 4 weeks before starting the study
  • Autoimmune diseases (conditions where the immune system attacks healthy cells) requiring systemic treatment
  • Pregnant or breastfeeding women
  • Unable to swallow oral medications
  • Any medical condition that could interfere with the study medication or make participation unsafe
  • Use of other experimental drugs within 4 weeks before starting the study
  • Impaired liver or kidney function based on specific blood test results
  • History of organ transplantation
  • Regular use of medications that could interact with the study drug
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Investigated drugs

  • S095035

    (MAT2A inhibitor) is an investigational medication being studied for treating advanced or metastatic solid tumors. It works by blocking an enzyme called MAT2A, which may help stop cancer growth in patients whose tumors have a specific genetic change (MTAP deletion).

  • TNG462

    is a medication being studied in combination with S095035. This combination therapy is being tested to see if the two medications working together can be more effective in treating advanced or metastatic solid tumors than S095035 alone.

What is already known about the treatment

  • S095035

    An investigational MAT2A inhibitor medication being studied in clinical trials for the treatment of advanced or metastatic solid tumors with MTAP deletion. This novel therapeutic agent is administered as a single agent or in combination with TNG462, with the primary goal of evaluating its safety, tolerability, and antitumor activity. The medication works by targeting the MAT2A enzyme, which plays a crucial role in cancer cell metabolism, particularly in tumors lacking the MTAP gene. Currently undergoing Phase 1/2 clinical trials, this drug represents a potential targeted therapy approach for patients with specific genetic tumor characteristics.

  • TNG462

    A clinical-stage investigational drug being studied in combination with S095035 for the treatment of advanced or metastatic solid tumors with MTAP deletion. This medication is being evaluated in Phase 1/2 clinical trials to determine its optimal dosing, safety profile, and therapeutic efficacy when used in combination therapy. The drug is being tested specifically in patients whose tumors show homozygous deletion of the MTAP gene, representing a targeted approach to cancer treatment based on specific genetic markers.

Investigated diseases

MTAP-deleted Solid Tumors - A condition characterized by the presence of solid tumors that have lost the MTAP (methylthioadenosine phosphorylase) gene through genetic deletion. These tumors can develop in various tissues and organs of the body. The loss of MTAP affects the metabolism of certain molecules in cancer cells, making them function differently from normal cells. The condition can progress from localized tumors to an advanced stage where cancer spreads to other parts of the body (metastasis). This type of tumor can occur in multiple organ systems and typically continues to grow over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-521249-25-00Protocol codeCL1-95035-001Estimated enrolment342 patientsSponsorInstitut De Recherches Internationales Servier IRIS

sourced from the EU Clinical Trials Register and site verification

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