Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RMC-6236, RAS inhibitor
Daraxonrasib · 10 trials · 31 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 Investigator.
OS is defined as the time from randomization until death from any cause.
DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator.
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 BICR.
OS is defined as the time from randomization until death from any cause.
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.
ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders.
Number, type, and severity of treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities in participants receiving SNV1521 plus daraxonrasib, used to identify doses suitable for further study, classified and graded according to CTCAE v6.0 and protocol-defined DLT criteria
Number of patients with AEs as assessed by CTCAE v5.
Number of patients with changes in vital signs.
Number of patients with changes in clinical laboratory test values.
Number of patients with dose limiting toxicities
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 |
|---|---|---|
| Arm A: daraxonrasib + zoldonrasib | EXPERIMENTAL | combination of study drugs |
| Arm B: gemcitabine and nab-paclitaxel | EXPERIMENTAL | chemotherapy |
| Arm A: daraxonrasib | EXPERIMENTAL | study drug |
| Arm B: daraxonrasib + gemcitabine and nab-paclitaxel | EXPERIMENTAL | study drug in combination with chemotherapy |
| Arm C: gemcitabine and nab-paclitaxel | ACTIVE_COMPARATOR | SOC chemotherapy |
| daraxonrasib | EXPERIMENTAL | study drug |
| SOC Observation | NO_INTERVENTION | Patients randomized to the comparator control arm will receive SOC observation. |
| docetaxel | ACTIVE_COMPARATOR | Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy. |
| 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) |
| Escalation | EXPERIMENTAL | Participants in this arm will take SNV1521 by mouth together with a RAS-targeted cancer medicine. The dose of SNV1521 will be increased in small steps to find a safe and tolerable dose of the combination in people with advanced pancreatic cancer. |
| Arm A: Daraxonrasib + Ivonescimab Combination | EXPERIMENTAL | Dose Exploration and Dose Expansion (+ Carboplatin/Cisplatin + Pemetrexed) |
| Arm B: Elironrasib + Ivonescimab Combination | EXPERIMENTAL | Dose Exploration and Dose Expansion. Dose Expansion will include two separate cohorts: Cohort B1 (+ daraxonrasib) and Cohort B2 (+ Carboplatin/Cisplatin + Pemetrexed). |
| Arm C: Zoldonrasib + Ivonescimab Combination | EXPERIMENTAL | Dose Exploration and Dose Expansion. Dose Expansion will include two separate cohorts: Cohort C1 and Cohort C2 (+ Cetuximab). |
| 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 |
| Subprotocol G: RAS G12D-mutated metastatic CRC | EXPERIMENTAL | RMC-9805 (QD) and cetuximab with FOLFIRI |
| 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 |
|---|---|---|
| daraxonrasib | DRUG | oral tablets |
| gemcitabine | DRUG | intravenous (IV) infusion |
| nab-paclitaxel | DRUG | IV infusion |
| zoldonrasib | DRUG | oral tablets |
| docetaxel | DRUG | intravenous (IV) infusion |
| RMC-6236 | DRUG | Oral Tablets |
| Irinotecan | DRUG | IV infusion |
| Liposomal irinotecan | DRUG | IV infusion |
| 5-fluorouracil | DRUG | IV infusion |
| leucovorin | DRUG | IV infusion |
| Oxaliplatin | DRUG | IV infusion |
| SNV1521 | DRUG | SNV1521 is an oral investigational anticancer drug. In this study, SNV1521 is administered at different dose levels together with the RAS inhibitor daraxonrasib in adults with locally advanced unresectable or metastatic pancreatic cancer. |
| Elironrasib | DRUG | oral tablets |
| Ivonescimab | DRUG | IV infusion |
| Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only) | DRUG | IV infusion |
| cetuximab (Cohort C2 Only) | DRUG | IV infusion |
| Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only) | DRUG | IV infusion |
| Daraxonrasib (Cohort B1 only) | DRUG | oral tablets |
| mFOLFOX6 regimen | DRUG | IV infusion |
| bevacizumab | DRUG | IV infusion |
| mFOLFIRINOX regimen | DRUG | IV infusion |
| cetuximab | DRUG | IV infusion |
| RMC-9805 | DRUG | Oral Tablet |
| FOLFIRI regimen | DRUG | IV infusion |
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 pancreatic adenocarcinoma, including adenosquamous carcinoma, not previously treated in the locally ad...
Daraxonrasib is an investigational small molecule RAS inhibitor being developed by Revolution Medicines, Inc. (ticker: RVMD) for advanced solid tumors. It is being studied in cancers including pancreatic cancer, biliary tract cancers, colorectal cancer, and non-small cell lung cancer. It is not yet approved and remains in clinical development.
Daraxonrasib is being evaluated for the treatment of advanced solid tumors, including pancreatic cancer, biliary tract cancers, colorectal cancer, and non-small cell lung cancer (NSCLC). It is an investigational therapy and has not been approved for any indication. Clinical trials are enrolling patients with these tumor types.
Daraxonrasib targets RAS, a protein that is frequently mutated in cancers such as pancreatic, colorectal, and lung tumors. By inhibiting RAS, the drug aims to block signaling pathways that drive tumor growth. It is a small molecule designed to address RAS-driven cancers.
Daraxonrasib is being developed by Revolution Medicines, Inc., which trades under the ticker RVMD. The company is running multiple clinical trials of daraxonrasib in advanced solid tumors, including pancreatic cancer and biliary tract cancers.
Daraxonrasib is in Phase 1 development, with additional Phase 2 and Phase 3 trials ongoing or planned. It is an investigational drug and has not been approved by the FDA. The clinical program includes studies in pancreatic cancer, biliary tract cancers, and other solid tumors.
Daraxonrasib is being studied in several clinical trials, including NCT07805954, a Phase 3 trial in metastatic KRAS G12D-mutated pancreatic adenocarcinoma; NCT07793253, a Phase 2 trial in recurrent KRAS-mutant biliary tract cancer; NCT07756281, a Phase 1 trial in advanced pancreatic cancer; and NCT07491445, a Phase 3 trial in metastatic pancreatic adenocarcinoma.
Yes, Daraxonrasib is also known as RMC-6236. Both names refer to the same investigational RAS inhibitor developed by Revolution Medicines, Inc. (RVMD). The alternative designation RMC-6236 may appear in scientific literature and earlier company communications.