In short
Clinical trials are investigating S-241656 in people with cancers that have KRAS, BRAF, and other selected RAS/MAPK mutations. These studies are looking at safety, tolerability, and early signs of antitumor activity in different patient groups, including use alone and in combination with other treatments.
Key points
- S-241656 is being studied in an early Phase 1/2 clinical trial for cancers with documented KRAS, BRAF, and other selected RAS/MAPK mutations. The study includes people with mutation-positive malignancies and tests the treatment both alone and in combination with other cancer medicines. In the first part of the trial, researchers are focused on safety, tolerability, and dose-limiting toxicities. In the later part, they are looking for early signs of tumor response. The trial is authorised and plans to enroll 567 participants.
Trial overview
The study NCT05786924 is an interventional study, which means researchers give a treatment and then measure what happens. It is testing S-241656 in people with cancers that have documented KRAS, BRAF, and other selected RAS/MAPK mutations.
The trial title shows that the research is focused on mutation-positive malignancies, meaning cancers with specific gene changes. The study is authorised and is designed to learn more about S-241656 in these patient groups.
Who the trial is for
This trial is for patients with malignancies that have documented KRAS, BRAF, or other selected RAS/MAPK mutations. In simple words, the study is not for all cancers; it is for cancers with certain gene changes that may help define who can take part.
The source data do not list every inclusion or exclusion rule, so the most important known target group is people with these mutation-positive cancers.
What is being tested
S-241656 is being studied both as monotherapy, which means treatment by itself, and in combination therapy, which means used together with other medicines. The combination treatments listed in the trial include several cancer medicines given by mouth or by vein.
The trial records show treatment combinations with medicines such as folinate de calcium, oxaliplatin, cetuximab, panitumumab, gemcitabine, irinotecan, and fluorouracil, among others. These names appear in the study record as part of the treatment plan being tested, not as a full treatment guide.
Study phases and endpoints
This is a Phase 1/2 trial. Phase 1 studies usually focus on safety and the right dose, while Phase 2 studies look more closely at whether the treatment shows early benefit.
In the dose escalation part, the main goal is to evaluate safety and tolerability, both when S-241656 is used alone and when it is used in combinations. The primary outcomes here include dose-limiting toxicities during the first 28-day cycle, as well as the number of adverse events and serious adverse events.
In the dose expansion part, the main goal is to evaluate antitumor activity, which means whether the treatment shows signs of working against the cancer. The primary endpoint in this part is objective response, meaning measurable tumor shrinkage or other clear improvement on study assessment.
Trial status and size
The trial status is listed as Authorised. The planned enrollment is 567 participants, which means the study aims to include that many people overall.
This is a fairly large early-phase study, so it is likely meant to gather both safety information and early signs of benefit across several mutation-positive cancer groups.