In breve
Clinical trials are studying Rmc-6291 in people with advanced RAS G12C-mutated non-small cell lung cancer and other advanced solid tumors. These studies are looking at safety, tolerability, and the best dose to use in combinations with pembrolizumab, with or without RMC-6236 and chemotherapy.
Punti chiave
- Rmc-6291 is being studied in an early Phase 1 clinical trial. The trial looks at people with advanced RAS G12C-mutated non-small cell lung cancer and other advanced RAS G12C-mutated solid tumors. Researchers are testing Rmc-6291 with pembrolizumab, with or without RMC-6236, and with or without chemotherapy. The main goals are to check safety, tolerability, and the best dose to use. The trial also measures dose-limiting toxicities, serious side effects, and changes in lab tests, ECGs, and vital signs.
Overview of the Rmc-6291 study
The main trial in the source data is NCT06162221, a study of Rmc-6291 and RMC-6236 with other anti-cancer agents in patients with RAS G12C-mutated NSCLC (non-small cell lung cancer). The study is authorised and is being done to learn about safety and tolerability in advanced cancer.
The brief summary says the study also aims to define the RP2DS, which means the recommended phase 2 dose and schedule, for Rmc-6291 when used with pembrolizumab, with or without RMC-6236 and with or without chemotherapy.
Who the trial is for
This study is focused on people with advanced RAS G12C-mutated solid tumors, and one key group is patients with advanced RAS G12C-mutated NSCLC. In simple words, this means the trial is for people whose cancer has a specific gene change called RAS G12C and is at an advanced stage.
The data do not list full inclusion or exclusion rules, so participation depends on the detailed trial criteria used by the study team.
Treatments being tested
The study tests Rmc-6291 in combination with pembrolizumab, and in some parts it may also include RMC-6236 and chemotherapy. The chemotherapy drugs named in the trial record include pemetrexed, cisplatin, and carboplatin.
This means the researchers are not only looking at Rmc-6291 alone, but at how it works as part of a treatment combination in advanced cancer.
Trial phase and study design
NCT06162221 is a Phase 1 study, which is an early stage of clinical research. Phase 1 trials usually focus on safety, tolerability, and dose finding rather than proving long-term benefit.
The study type is interventional, which means the researchers assign treatments and then observe what happens. The planned enrollment is 267 participants.
What the study measures
The primary outcome includes the incidence of dose-limiting toxicities (DLTs) in selected parts of the study. A dose-limiting toxicity is a side effect that is serious enough to limit how much treatment can be given.
The trial also measures treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), and clinically significant changes in laboratory test values, ECGs, and vital signs. These measures help the team understand whether the treatment is causing safety problems during the study.
What the medical terms mean
NSCLC stands for non-small cell lung cancer, which is a common type of lung cancer. RAS G12C mutation means a specific change in a cancer-related gene, and the study only looks at cancers with this change.
ECG means electrocardiogram, a test that checks the heart’s electrical activity. Vital signs are basic body measurements such as pulse, blood pressure, and temperature, which help show how a person is doing during treatment.
Laboratory test values are results from blood or other tests that help the team watch for safety changes during the trial.