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S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP

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Servier Protocol Code: CL1-95035-001 Sponsor: Servier Bio-Innovation LLC Clinicaltrials.gov Identifier: NCT06188702 EU Trial (CTIS) Number: 2025-521249-25-00

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How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 33 locations

Study description

This study aims to test a new study drug, S095035, as a single medication or in combination with another drug called TNG462. Researchers will test these new study drugs in participants with advanced solid tumors that have a specific change in a gene called MTAP. This specific change is the loss of the MTAP gene. Scientists call this a deletion. The loss of MTAP is thought to help tumors grow.

The MTAP gene makes an enzyme (MTAP) that breaks down a molecule called MTA. In patients who have cancer with an MTAP loss, the enzyme cannot be produced. The absence of the MTAP enzyme leads to a buildup of MTA that affects the normal function of the PRMT5 enzyme.

S095035 acts by blocking an enzyme called MAT2A. By blocking the MAT2A enzyme, S095035 indirectly prevents the PRMT5 enzyme from working, which ultimately leads to tumor cell death. TNG462 acts by directly blocking the PRMT5 enzyme.

Researchers believe that, by preventing PRMT5 from working in cancer cells without MTAP, S095035 alone or with TNG462 could stop these cancer cells from growing.

The study is split into two parts. In the first part of the study, the main goals are:

  • To look at the safety of S095035 alone and with TNG462 and whether participants tolerate them.
  • To find the highest dose of S095035 alone and with TNG462 that participants can take without too much risk (highest tolerated dose).
  • To find the dose of S095035 alone and with TNG462 that is both safe and effective (the recommended dose) for use in study part 2.

In the second part of the study, the main goal is:

  • To see how well S095035 alone and with TNG462 work in treating the tumor.
Official 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
Protocol
English (USA)
Conditions
MTAP-deleted Solid Tumors
Interventions / Treatments
  • S095035
  • TNG462
Other study id numbers
  • CL1-95035-001

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants have to:

  • Be adults aged 18 or older.
  • Have solid tumors with MTAP loss:
    • That have spread to surrounding tissues or lymph nodes or to other parts of the body.
    • That have worsened despite treatment and with no other standard treatment available.
  • Be able to provide a sample of their tumor. This involves a minor surgical procedure to remove a piece of the tumor from the body. Scientists call this a biopsy.

 

 

Participants cannot take part in the study if:

  • They have another type of active cancer besides the one being studied (solid tumor with MTAP loss).
  • They receive any anticancer treatment or radiation less than two weeks before starting the study.

 

 

How is the study designed?

Allocation
Non-randomized
Interventional study model
Sequential
Participant Group / Arm
Experimental: Part 1 Arm 1 - S095035 alone: dose escalation

The dose of S095035 is gradually increased to find the dose that is safe and effective (recommended dose) for the treatment of the participant’s cancer.

Intervention / Treatment
Drug: S095035

Participants receive S095035 orally once daily in 28-day cycles.

Participant Group / Arm
Experimental: Part 1 Arm 2 - S095035-TNG462 combination: dose escalation

The dose of S095035 with TNG462 is gradually increased to find the dose that is safe and effective (recommended dose) for the treatment of the participant’s cancer.

Intervention / Treatment
Drug: S095035

Participants receive S095035 orally once daily in 28-day cycles.

Drug: TNG462

Participants receive TNG462 orally once daily in 28-day cycles.

Participant Group / Arm
Experimental: Part 2 Arm 1a NSCLC - S095035 alone: dose expansion

Participants with Non-Small Cell Lung Cancer (NSCLC) are given the recommended dose of S095035 found in Part 1.

Intervention / Treatment
Drug: S095035

Participants receive S095035 orally once daily in 28-day cycles.

Participant Group / Arm
Experimental: Part 2 Arm 1b BTC - S095035 alone: dose expansion

Participants with Biliary Tract Cancer (BTC) are given the recommended dose of S095035 found in Part 1.

Intervention / Treatment
Drug: S095035

Participants receive S095035 orally once daily in 28-day cycles.

Participant Group / Arm
Experimental: Part 2 Arm 1c PDAC - S095035 alone: dose expansion

Participants with Pancreatic Ductal Adenocarcinoma (PDAC) are given the recommended dose of S095035 found in Part 1.

Intervention / Treatment
Drug: S095035

Participants receive S095035 orally once daily in 28-day cycles.

Participant Group / Arm
Experimental: Part 2 Arm 1d Basket arm - S095035 alone: dose expansion

Participants are given the recommended dose of S095035 found in Part 1.

Intervention / Treatment
Drug: S095035

Participants receive S095035 orally once daily in 28-day cycles.

Participant Group / Arm
Experimental: Part 2 Arm 2a BTC - S095035-TNG462 combination: dose expansion

Participants with Biliary Tract Cancer (BTC) are given the recommended dose of the S095035-TNG462 combination found in Part 1.

Intervention / Treatment
Drug: S095035

Participants receive S095035 orally once daily in 28-day cycles.

Drug: TNG462

Participants receive TNG462 orally once daily in 28-day cycles.

Participant Group / Arm
Experimental: Part 2 Arm 2b Gastroesophageal - S095035-TNG462 combination: dose expansion

Participants with gastroesophageal cancer are given the recommended dose of the S095035-TNG462 combination found in Part 1.

Intervention / Treatment
Drug: S095035

Participants receive S095035 orally once daily in 28-day cycles.

Drug: TNG462

Participants receive TNG462 orally once daily in 28-day cycles.

Participant Group / Arm
Experimental: Part 2 Arm 2c PDAC - S095035-TNG462 combination: dose expansion

Participants Pancreatic Ductal Adenocarcinoma (PDAC) are given the recommended dose of the S095035-TNG462 combination found in Part 1

Intervention / Treatment
Drug: S095035

Participants receive S095035 orally once daily in 28-day cycles.

Drug: TNG462

Participants receive TNG462 orally once daily in 28-day cycles.

Keywords

Provided by Servier
MAT2A MTAP Solid Tumors PRMT5 SAM Synthetic Lethality MTAP deletion MAT2A Inhibitor Advanced Solid Tumors Biliary Tract Cancer Non-small Cell Lung Cancer Pancreatic Adenocarcinoma Gastroesophageal Cancer
Additional Relevant MeSH Terms Glioma
Biliary Tract Neoplasms Carcinoma, Non-Small-Cell Lung