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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Hospital Quironsalud Barcelona	Barcelona	Spain
Odense University Hospital	Odense	Denmark
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Rigshospitalet	Copenhagen	Denmark
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Akorlhseld Pvuhdzzd Htfvsljo Dg Mrwuzrcwz	Marseille	France
Ubhwfunzqmyhzocqmilop Dvlffcpcvbp Ayp	Duesseldorf	Germany
Hwnufkpw Vbyp dnwbgomz	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	30.10.2025
France	Not recruiting	30.10.2025
Germany	Not recruiting	30.10.2025
Italy	Not recruiting	30.10.2025
Spain	Not recruiting	30.10.2025

Trial locations

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.

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 ID:

2025-521249-25-00

Protocol code:

CL1-95035-001

NCT ID:

NCT06188702

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?