A Phase 1/2 interventional study of RMC-6236 and mFOLFOX6 regimen in Colorectal Cancer, CRC and Pancreatic Ductal Adenocarcinoma, sponsored by Revolution Medicines, Inc.. Recruiting at 32 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Revolution Medicines, Inc. · Phase 1/2, Interventional, and Treatment
The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents.
The current subprotocols include the following:
Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens
Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6
Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel
Subprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens
Subprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6
Subprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel
Subprotocol G: RMC-9805 + cetuximab + FOLFIRI
The platform study design allows combinations of RAS(ON) inhibitors with other anticancer agents to be evaluated in patients with RAS-mutated solid tumors with a focus on GI cancers.
This is an open-label platform study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard of Care (SOC) or with novel agents, and to define the Recommended Phase 2 Dose and Schedule (RP2DS). Enrollment of patients with RAS mutations will be specified in each subprotocol.
Subprotocol A is an open-label, multicenter study of RMC-6236 in combination with 5-fluorouracil-based regimens in patients with treatment-naïve unresectable or metastatic colorectal cancer or treatment-naïve metastatic pancreatic ductal adenocarcinoma. Subprotocol B is an open-label, multicenter study of RMC-6236 in combination with cetuximab with or without mFOLFOX6 in patients with unresectable or metastatic colorectal cancer or patients with previously treated or treatment-naïve metastatic pancreatic ductal adenocarcinoma. Subprotocol C is an open-label, multicenter study of RMC-6236 in combination with gemcitabine and nab-paclitaxel in patients with treatment-naïve metastatic pancreatic ductal adenocarcinoma. Subprotocol D is an open-label, multicenter study of RMC-9805 with or without RMC-6236 in combination with 5-fluorouracil-based regimens in patients with RAS G12D-mutant unresectable or metastatic colorectal cancer or metastatic pancreatic ductal adenocarcinoma. Subprotocol E is an open-label, multicenter study of RMC-9805 with or without RMC-6236 in combination with cetuximab-based therapies with or without mFOLFOX6 in patients with RAS G12D-mutant unresectable or metastatic colorectal cancer or metastatic pancreatic ductal adenocarcinoma. Subprotocol F is an open-label, multicenter study of RMC-9805 with or without RMC-6236 in combination with gemcitabine and nab-paclitaxel in patients with RAS G12D-mutant metastatic pancreatic ductal adenocarcinoma. Subprotocol G is an open-label, multicenter study of RMC-9805 with cetuximab and FOLFIRI in patients with previously treated, RAS G12D-mutated metastatic colorectal cancer.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 1,130 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Revolution Medicines, Inc. is the lead sponsor of 20 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All Patients (unless otherwise noted):
Exclusion Criteria:
All Patients:
Other inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RMC-6236 (QD) and bevacizumab with 5-fluorouracil-based regimens
Drug: RMC-6236 · Drug: mFOLFOX6 regimen · Drug: bevacizumab · Drug: mFOLFIRINOX regimen
RMC-6236 (QD) and cetuximab with or without mFOLFOX6
Drug: RMC-6236 · Drug: mFOLFOX6 regimen · Drug: cetuximab
RMC-6236 (QD) and gemcitabine with nab-paclitaxel
Drug: RMC-6236 · Drug: gemcitabine · Drug: nab-paclitaxel
RMC-9805 (QD or BID) with or without RMC-6236 (QD), and bevacizumab with 5-fluorouracil- based regimens
Drug: RMC-6236 · Drug: mFOLFOX6 regimen · Drug: bevacizumab · Drug: mFOLFIRINOX regimen · Drug: RMC-9805
RMC-9805 (QD or BID) with or without RMC-6236 (QD), and cetuximab with or without mFOLFOX6
Drug: RMC-6236 · Drug: mFOLFOX6 regimen · Drug: cetuximab · Drug: RMC-9805
RMC-9805 (QD or BID) with or without RMC-6236 (QD), and gemcitabine with nab-paclitaxel
Drug: RMC-6236 · Drug: gemcitabine · Drug: nab-paclitaxel · Drug: RMC-9805
RMC-9805 (QD) and cetuximab with FOLFIRI
Drug: cetuximab · Drug: RMC-9805 · Drug: FOLFIRI regimen
Oral tablet
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
Oral Tablet
IV infusion
Adverse events (Subprotocols A-F)
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.
Time frame: Up to 3 years
Dose limiting toxicities (Subprotocols A-F)
Number of participants with dose limiting toxicities
Time frame: 28 days
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by Blinded Independent Central Review (BICR)(Subprotocol G)
Time frame: Up to 3 years
Pharmacokinetics of RMC-6236 (Subprotocols A-F)
Blood concentration of RMC-6236 over time
Time frame: 21 weeks
Pharmacokinetics of RMC-9805 (Subprotocols D-G)
Blood concentration of RMC-9805 over time
Time frame: 21 weeks
ORR assessed by Investigator (Subprotocols A-G)
Overall Response Rate per RECIST v1.1
Time frame: Up to 3 years
DOR (Subprotocols A-G)
Duration of Response per RECIST v1.1
Time frame: Up to 3 years
DCR (Subprotocols A-G)
Incidence of Response per RECIST v1.1
Time frame: Up to 3 years
TTR (Subprotocols A-G)
Time to Response per RECIST v1.1
Time frame: Up to 3 years
PFS (Subprotocols A-G)
Progression Free Survival per RECIST v1.1
Time frame: Up to 3 years
PFS Rate at 6 and 12 Months (Subprotocol G)
Time frame: Up to 3 years
OS (Subprotocols A-F)
Overall Survival
Time frame: Up to 3 years
Overall Survival Rate at 12 Months (Subprotocol G)
Time frame: Up to 3 years
Number of Participants with Adverse Events (Subprotocol G)
Time frame: Up to 3 years
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Studies of the drugs tested here: Daraxonrasib · Cetuximab · Zoldonrasib