Table of contents
- Trial overview
- Who the trial is for
- What is being tested
- Study phases and endpoints
- Trial status and size
Trial overview
The study NCT05786924 is an interventional study, which means researchers give a treatment and then measure what happens.[1] It is testing S-241656 in people with cancers that have documented KRAS, BRAF, and other selected RAS/MAPK mutations.[1]
The trial title shows that the research is focused on mutation-positive malignancies, meaning cancers with specific gene changes.[1] The study is authorised and is designed to learn more about S-241656 in these patient groups.[1]
Who the trial is for
This trial is for patients with malignancies that have documented KRAS, BRAF, or other selected RAS/MAPK mutations.[1] 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.[1]
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.[1]
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.[1] The combination treatments listed in the trial include several cancer medicines given by mouth or by vein.[1]
The trial records show treatment combinations with medicines such as folinate de calcium, oxaliplatin, cetuximab, panitumumab, gemcitabine, irinotecan, and fluorouracil, among others.[1] These names appear in the study record as part of the treatment plan being tested, not as a full treatment guide.[1]
Study phases and endpoints
This is a Phase 1/2 trial.[1] 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.[1]
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.[1] 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.[1]
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.[1] The primary endpoint in this part is objective response, meaning measurable tumor shrinkage or other clear improvement on study assessment.[1]
Trial status and size
The trial status is listed as Authorised.[1] The planned enrollment is 567 participants, which means the study aims to include that many people overall.[1]
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.[1]
