In short
Clinical trials are studying Rmc-6291 in people with advanced RAS G12C-mutated solid tumors, especially non-small cell lung cancer (NSCLC). These trials aim to check safety, tolerability, and the best dose to use in combination with other cancer treatments.
Key points
- Clinical trials of Rmc-6291 are studying advanced RAS G12C-mutated solid tumors, with a focus on non-small cell lung cancer (NSCLC). The trial is in Phase 1, so it is mainly checking safety, tolerability, and the best dose for later studies. It is testing Rmc-6291 with pembrolizumab, with or without RMC-6236, and with or without chemotherapy. The study plans to enroll 267 people. Main endpoints include dose-limiting toxicities, treatment-related side effects, serious side effects, and changes in lab tests, ECGs, and vital signs.
Trial overview
The available trial is NCT06162221, a Phase 1 interventional study of Rmc-6291 in people with advanced RAS G12C-mutated solid tumors, with a specific focus on advanced RAS G12C-mutated NSCLC.
The study is authorised and plans to enroll 267 participants.
Who the study is for
This trial is designed for patients with advanced RAS G12C-mutated solid tumors, and the brief summary also names advanced RAS G12C-mutated NSCLC as a key target group.
NSCLC means non-small cell lung cancer, which is the most common type of lung cancer.
The trial data do not list all entry rules here, but they show that the study is aimed at people whose cancer has the RAS G12C mutation.
What the study is testing
The study is testing Rmc-6291 in combination with pembrolizumab, with or without RMC-6236, and with or without chemotherapy.
The chemotherapy drugs listed in the trial data include pemetrexed, cisplatin, and carboplatin, along with several listed product names for these medicines.
The main goal is to see whether these combinations are safe and tolerable in the target patient groups.
Study phase and size
This is a Phase 1 trial, which means it is an early study that mainly looks at safety and dose selection.
The brief summary says the study aims to define the RP2DS, which means the recommended dose for a phase 2 study.
The planned enrollment is 267 people, which is the number of participants the study aims to include.
What the study measures
The primary outcome includes the incidence of dose-limiting toxicities, which are side effects serious enough to limit further dose increases.
The study also measures treatment-emergent adverse events, treatment-related adverse events, and serious adverse events.
In addition, the trial checks for clinically significant changes in laboratory test values, ECGs, and vital signs.
What the trial means for patients
For patients, this trial is mainly about early testing of Rmc-6291 in cancer combinations, not yet about proving long-term benefit.
Because it is a Phase 1 study, the main focus is on learning how the treatment combinations behave in the body of people with these cancers and whether the doses can be used safely.
The study may help guide later research in advanced RAS G12C-mutated NSCLC and other solid tumors with the same mutation.