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S095035

Clinical trials are investigating S095035 in adults with advanced or metastatic solid tumors that have MTAP deletion. These studies are looking at safety, tolerability, dose finding, and how well the treatment works alone or with TNG462.

Table of Contents

Trial overview

The main study of S095035 is interventional, which means researchers give the study treatment and then watch what happens.[1] It is a phase 1/2 trial, so it begins by checking safety and dose, then moves on to early signs of benefit.[1]

This study is in adults with advanced or metastatic solid tumors that have MTAP deletion.[1] The trial is authorised.[1]

Who can join the study

The trial is designed for adult participants with advanced or metastatic solid tumors.[1] The tumors must have a specific change called homozygous deletion of MTAP, which means both copies of the MTAP gene are missing in the tumor cells.[1]

This is a targeted research group, so not every cancer patient can join.[1] The study focuses on people whose tumors match the genetic feature named in the trial data.[1]

What is being measured

In phase 1, the study measures dose-limiting toxicities, which are side effects serious enough to limit treatment during the first cycle.[1] It also records adverse events and serious adverse events, plus changes in safety lab tests, physical exam findings, vital signs, electrocardiogram results, and ECOG performance status.[1]

These safety checks help researchers decide the recommended dose and/or the maximum tolerated dose.[1] The goal is to find a dose that can be studied further while watching closely for problems during treatment.[1]

In phase 2, the main endpoint is objective response rate, meaning the percentage of patients whose tumors shrink or disappear by standard rules.[1] The study uses RECIST 1.1 or RANO 2.0 criteria, and results are checked by the investigator and by blinded independent central review.[1]

Study design and treatment groups

The trial studies S095035 as a single agent and also in combination with TNG462.[1] The treatment names listed in the source include S095035 tablet 25 mg and 50 mg, and TNG462 given by oral use.[1]

The brief summary says phase 1 is meant to assess safety and tolerability and to identify the recommended dose and/or maximum tolerated dose.[1] Phase 2 is meant to assess antitumor activity, which means early evidence that the treatment may work against the cancer.[1]

Trial status and size

The trial status is listed as Authorised.[1] The planned enrollment is 342 participants.[1]

Only one trial was provided in the source data, so the article focuses on this study.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06188702 Phase 1/2 MTAP-deleted advanced or metastatic solid tumors Authorised 342

FAQ

  • What is being studied in the S095035 trials? The trials are studying S095035 alone and in combination with TNG462. They aim to learn about safety in phase 1 and antitumor activity, or how well the treatment works against tumors, in phase 2.
  • Who can join these trials? The study is for adult participants with advanced or metastatic solid tumors and homozygous deletion of MTAP. This means the cancer has spread or is very advanced, and the tumor has a specific gene deletion.
  • What phases are included? This is a phase 1/2 trial. Phase 1 focuses on safety, side effects, and finding the right dose. Phase 2 looks at early signs of how well the treatment works.
  • What results are the researchers measuring? In phase 1, they measure dose-limiting toxicities, adverse events, serious adverse events, lab changes, physical exam findings, vital signs, ECG changes, and ECOG performance status. In phase 2, they measure objective response rate using RECIST 1.1 or RANO 2.0 criteria.
  • What does authorized mean for this study? Authorized means the trial has been approved to start. It does not mean the results are already known, only that the study can begin enrolling or has permission to proceed.

Ongoing Clinical Trials on S095035

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

    Not recruiting

    2 1 1
    Investigated drugs:
    Denmark France Germany Italy Spain

Glossary

  • Advanced solid tumor: A cancer that has grown beyond its original site and is harder to treat.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • MTAP deletion: A missing part of a gene called MTAP in the tumor. The study is focused on cancers with this change.
  • Homozygous deletion: Both copies of a gene are missing in the tumor cells.
  • Phase 1: The first part of a clinical trial, usually focused on safety, side effects, and dose finding.
  • Phase 2: A later trial phase that looks more closely at whether the treatment may work.
  • Dose-limiting toxicities: Side effects that are serious enough to limit how much of the study treatment can be given.
  • Adverse events: Any unwanted medical problem that happens during a study.
  • Serious adverse events: Unwanted medical problems that are severe, life-threatening, or need hospital care.
  • ECOG performance status: A scale that shows how well a person can do daily activities.
  • RECIST 1.1: A standard way to measure whether tumors shrink, stay the same, or grow.
  • RANO 2.0: A standard used to assess tumor response, especially in brain tumors and related cancers.

References