Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RMC-6236 · 3 trials · 12 indications
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by blinded independent central review (BICR)
OS is defined as the time from randomization until death from any cause.
Evaluate the safety and tolerability in the study population characterized by incidence, abnormal laboratory assessments, severity, and seriousness of adverse events in relation to the study treatment.
Number of participants with dose limiting toxicities
| Arm | Type | Description |
|---|---|---|
| RMC-6236 | EXPERIMENTAL | Study drug |
| Investigator's choice of standard of care therapy | ACTIVE_COMPARATOR | Patients randomized to Investigator's choice of standard of care chemotherapy will receive one of the following four treatments: * Gemcitabine and nab-paclitaxel (GnP) * Oxaliplatin, leucovorin, irinotecan, and 5-FU (Modified FOLFIRINOX: mFOLFIRINOX) * Liposomal irinotecan (Nal-IRI + 5-FU/LV) * Oxaliplatin, leucovorin and 5-FU IV (FOLFOX) |
| Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDAC | EXPERIMENTAL | RMC-6236 (QD) and Bevacizumab with 5-fluorouracil-based regimens |
| Subprotocol B: RAS-mutated unresectable or metastatic CRC or metastatic PDAC | EXPERIMENTAL | RMC-6236 (QD) and Cetuximab with or without mFOLFOX6 |
| Subprotocol C: metastatic PDAC | EXPERIMENTAL | RMC-6236 (QD) and Gemcitabine with Nab-paclitaxel |
| Subprotocol D: RAS G12D-mutated unresectable or metastatic CRC or metastatic PDAC | EXPERIMENTAL | RMC-9805 (QD or BID) with or without RMC-6236 (QD), and Bevacizumab with 5-fluorouracil- based regimens |
| Subprotocol E: RAS G12D-mutated unresectable or metastatic CRC or metastatic PDAC | EXPERIMENTAL | RMC-9805 (QD or BID) with or without RMC-6236 (QD), and Cetuximab with or without mFOLFOX6 |
| Subprotocol F: RAS G12D-mutated metastatic PDAC | EXPERIMENTAL | RMC-9805 (QD or BID) with or without RMC-6236 (QD), and Gemcitabine with Nab-paclitaxel |
| Experimental: RMC-6236 | EXPERIMENTAL | Enrollment into dose exploration may be from any advanced solid tumor type with KRAS p.G12 mutations. Enrollment into dose expansion/optimization may be from groups consisting of patients with a single histotype/genotype (for example, KRAS G12-mutated NSCLC, PDAC, CRC, RAS mutant NSCLC, Melanoma, gynecological cancer or other solid tumors not previously specified). RAS mutant is defined as any nonsynonymous mutation of KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61) |
| Name | Type | Description |
|---|---|---|
| RMC-6236 | DRUG | Oral Tablets |
| Gemcitabine | DRUG | intravenous (IV) infusion |
| nab-paclitaxel | DRUG | IV infusion |
| Irinotecan | DRUG | IV infusion |
| Liposomal irinotecan | DRUG | IV infusion |
| 5-fluorouracil | DRUG | IV infusion |
| leucovorin | DRUG | IV infusion |
| Oxaliplatin | DRUG | IV infusion |
| mFOLFOX6 regimen | DRUG | IV infusion |
| bevacizumab | DRUG | IV infusion |
| mFOLFIRINOX regimen | DRUG | IV infusion |
| cetuximab | DRUG | IV infusion |
| RMC-9805 | DRUG | Oral Tablet |
Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically or cytologically confirmed PDAC with metastatic disease. * Measurable disease per RECIST 1.1. * Adequate organ function (bone mar...
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RMC-6236 is an investigational small molecule being studied for the treatment of RAS-mutant cancers, including colorectal cancer, pancreatic cancer, and non-small cell lung cancer (NSCLC). It is also being evaluated in pancreatic ductal adenocarcinoma (PDAC) and other advanced solid tumors harboring specific RAS mutations.
RMC-6236 targets RAS, a protein that regulates cell growth and division. Mutations in RAS can drive uncontrolled cell proliferation, contributing to cancer development. By inhibiting RAS, RMC-6236 aims to block this oncogenic signaling in tumors with specific RAS mutations.
RMC-6236 is being developed by Revolution Medicines, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RVMD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with RAS-mutant cancers.
RMC-6236 is in Phase 1 clinical development. It is being studied in early-stage trials for advanced solid tumors with RAS mutations, including a Phase 1 study in gastrointestinal cancers. The drug is investigational and has not yet been approved by regulatory authorities.
RMC-6236 is being evaluated in three clinical trials. NCT05379985 is a Phase 1 study in advanced solid tumors with RAS mutations. NCT06445062 is a Phase 1 study of RAS(ON) inhibitors in gastrointestinal tumors. NCT06625320 is a Phase 3 study in previously treated metastatic pancreatic ductal adenocarcinoma.
Yes, RMC-6236 is also known as daraxonrasib. In clinical trials, it is referred to by both names, with daraxonrasib used in the Phase 3 study for pancreatic cancer. This alternative name helps identify the drug across different research contexts.