In short
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.
Key points
- S095035 is being studied in adults with advanced or metastatic solid tumors that have MTAP deletion. The main trial is a phase 1/2 study, so it first checks safety, tolerability, and dose finding, then looks at early signs of how well the treatment works. The study tests S095035 alone and together with TNG462. Researchers are measuring safety outcomes in phase 1 and objective response rate in phase 2. The trial is authorised and plans to include 342 participants.
Trial overview
The main study of S095035 is interventional, which means researchers give the study treatment and then watch what happens. It is a phase 1/2 trial, so it begins by checking safety and dose, then moves on to early signs of benefit.
This study is in adults with advanced or metastatic solid tumors that have MTAP deletion. The trial is authorised.
Who can join the study
The trial is designed for adult participants with advanced or metastatic solid tumors. 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.
This is a targeted research group, so not every cancer patient can join. The study focuses on people whose tumors match the genetic feature named in the trial data.
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. 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.
These safety checks help researchers decide the recommended dose and/or the maximum tolerated dose. The goal is to find a dose that can be studied further while watching closely for problems during treatment.
In phase 2, the main endpoint is objective response rate, meaning the percentage of patients whose tumors shrink or disappear by standard rules. The study uses RECIST 1.1 or RANO 2.0 criteria, and results are checked by the investigator and by blinded independent central review.
Study design and treatment groups
The trial studies S095035 as a single agent and also in combination with TNG462. The treatment names listed in the source include S095035 tablet 25 mg and 50 mg, and TNG462 given by oral use.
The brief summary says phase 1 is meant to assess safety and tolerability and to identify the recommended dose and/or maximum tolerated dose. Phase 2 is meant to assess antitumor activity, which means early evidence that the treatment may work against the cancer.
Trial status and size
The trial status is listed as Authorised. The planned enrollment is 342 participants.
Only one trial was provided in the source data, so the article focuses on this study.