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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