Clinical Trials
Select Clinical Trials of RAS(ON) Inhibitors
At Revolution Medicines we are committed to the discovery, development, and delivery of targeted therapies for patients with RAS mutant cancer. Our RAS(ON) Inhibitor Clinical Trial Program is evaluating molecules aimed at targeting a broad range of RAS mutant cancers. Rat sarcoma (RAS) is a protein that is important in regulating cell division in our bodies. In certain cancers known as RAS mutant cancers, changes (or mutations) in the RAS gene cause the RAS protein to become mostly switched ON (or active), allowing the cancer cells to grow, spread, and survive.
Investigational RAS(ON) inhibitors currently under development include:
- Daraxonrasib (RMC-6236), an oral, RAS(ON) multi-selective inhibitor that is selective for the active or “(ON)" state of multiple mutant forms of RAS (G12X, G13X, Q61X)
- Zoldonrasib (RMC-9805), an oral, RAS(ON) mutant-selective inhibitor that is selective for the active or “(ON)" state of RAS G12D
- Elironrasib (RMC-6291), an oral, RAS(ON) mutant-selective inhibitor that is selective for the active or “(ON)" state of RAS G12C
RAS(ON) Inhibitor Clinical Trial Locator
RAS(ON) Inhibitor Clinical Trial Program
Showing all trials
Type of cancer
Pancreatic ductal adenocarcinoma (PDAC)
Trial Description
RASolute 304 is a Phase 3 study designed to evaluate whether daraxonrasib (RMC-6236) will improve disease-free survival (DFS) compared to standard of care (SOC) observation in patients with resected PDAC who have completed neoadjuvant and/or adjuvant chemotherapy
Select Eligibility Criteria:
- Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease
- Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy
- Must have completed most recent treatment within the past 12 weeks
- Documented RAS mutation status
Status:
(Recruitment status may vary by trial siteb)
actively recruiting
For more information:
NCT07252232
Type of cancer
Non-small cell lung cancer (NSCLC)
Trial Description
RASolve 301 is a Phase 3 trial designed to evaluate daraxonrasib (RMC‑6236) compared to docetaxel chemotherapy in patients with previously treated, locally advanced or metastatic RAS‑mutated NSCLC
Select Eligibility Criteria:
- Confirmed locally advanced or metastatic disease
- Documented RAS mutation status
- No prior therapy with direct RAS‑targeted therapy or docetaxel
- No untreated central nervous system metastatic disease
Status:
(Recruitment status may vary by trial siteb)
Actively Recruiting
For more information:
NCT06881784
Type of cancer
Pancreatic ductal adenocarcinoma (PDAC)
Trial Description
RASolute 302 is a Phase 3 study that compares the RAS(ON) inhibitor daraxonrasib (RMC‑6236) with standard of care chemotherapy in patients with PDAC that has spread to other parts of the body (metastatic) and has been previously treated
Select Eligibility Criteria:
- Male or female 18 years or older
- Documented RAS mutation status, either mutant or wild type
- RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61)
- Previously treated with 1 prior line of therapy with 5-fluorouracil (5-FU) based or gemcitabine-based regimen
- No history of known central nervous system metastatic disease
- No previous RAS‑directed therapies
- No major surgery within 4 weeks of starting the trial
Status:
(Recruitment status may vary by trial siteb)
active, not recruiting
For more information:
NCT06625320
Type of cancer
Non-small cell lung cancer (NSCLC)
Trial Description
RMC-LUNG-101 is a Phase 1b/2 study investigating 3 RAS(ON) inhibitors, elironrasib (RMC-6291), zoldonrasib (RMC-9805) and/or daraxonrasib (RMC-6236), with SOC, or zoldonrasib as monotherapy, in patients with advanced or metastatic NSCLC or other advanced solid tumors
Select Eligibility Criteria:
- Male or female 18 years or older
- KRAS G12C, RAS G12D, or other RAS mutations
- Received prior standard therapy appropriate for tumor type and stage
- No major surgery
<28 days of first dose - No primary central nervous system tumors
- No active or history of interstitial lung disease or pneumonitis requiring steroids
Status:
(Recruitment status may vary by trial siteb)
actively recruiting
For more information:
NCT06162221
Type of cancer
Advanced solid tumors, including PDAC, NSCLC, and colorectal cancer (CRC)
Trial Description
RMC-9805-001 is a Phase 1/1b study that investigates zoldonrasib (RMC-9805) alone or in combination with daraxonrasib (RMC‑6236) in patients with advanced or metastatic solid tumors, such as NSCLC, PDAC, and CRC
Select Eligibility Criteria:
- Male or female 18 years or older
- KRAS G12D mutation
- Received prior therapy
- No previous RAS‑directed therapies
- No primary central nervous system tumors or active brain metastasis
Status:
(Recruitment status may vary by trial siteb)
actively recruiting
For more information:
NCT06040541
Type of cancer
Advanced solid tumors, including PDAC, NSCLC, and colorectal cancer (CRC)
Trial Description
RMC-GI-102 is a Phase 1/2 study that investigates 2 RAS(ON) inhibitors (daraxonrasib [RMC-6236] and zoldonrasib [RMC-9805]) combined with the standard of care or other new therapeutics in patients with metastatic solid tumors, such as CRC and PDAC
Select Eligibility Criteria:
- Male or female 18 years or older
- RAS mutations, including G12D
- No primary central nervous system tumors or impaired gastrointestinal function
- No major surgery within 28 days of first dose
Status:
(Recruitment status may vary by trial siteb)
actively recruiting
For more information:
NCT06445062
Type of cancer
Advanced solid tumors, including PDAC, NSCLC, and colorectal cancer (CRC)
Trial Description
RMC-6291-101 is a Phase 1b study investigating the combination of RAS(ON) inhibitors elironrasib (RMC-6291) and daraxonrasib (RMC‑6236) in patients with advanced or metastatic solid tumors, such as NSCLC, CRC, and PDAC
Select Eligibility Criteria:
- Male or female 18 years or older
- KRAS G12C mutation
- Received previous treatment
- No primary central nervous system tumors or active brain metastasis
- No major surgery within 28 days of first dose
- No minor procedures within 7 days of treatment
Status:
(Recruitment status may vary by trial siteb)
actively recruiting
For more information:
NCT06128551
Type of cancer
Advanced solid tumors, including PDAC, NSCLC, and colorectal cancer (CRC)
Trial Description
RMC-6291-001 is a Phase 1/1b dose-escalation and dose-expansion study investigating the RAS(ON) inhibitor elironrasib (RMC-6291) in patients with advanced or metastatic solid tumors, including NSCLC, CRC, and PDAC
Select Eligibility Criteria:
- Male or female 18 years or older
- KRAS G12C mutation
- No primary central nervous system tumors or active brain metastasis
- No major surgery within 28 days of first dose
- No minor procedures within 7 days of treatment
- Previously treated with standard of care (SOC) therapies for their respective tumor types, is intolerant to, or is considered ineligible for, SOC anticancer treatments
- No previous treatment with a KRAS G12C(ON) inhibitor
Status:
(Recruitment status may vary by trial siteb)
active, not recruiting
For more information:
NCT05462717
Type of cancer
Advanced solid tumors, including PDAC, NSCLC, and colorectal cancer (CRC)
Trial Description
RMC-6236-001 a Phase 1/2 study that investigates the RAS(ON) inhibitor daraxonrasib (RMC‑6236) in adult patients with advanced solid tumors, including NSCLC, CRC, and PDAC
Select Eligibility Criteria:
- Male or female 18 years or older
- KRAS G12 or RAS mutations
- Treatment naïve or received prior standard therapy appropriate for tumor type and stage
- No central nervous system tumors or active brain metastasis
- No history of an unstable medical condition that could affect their ability to take part in the trial
Status:
(Recruitment status may vary by trial siteb)
actively recruiting
For more information:
NCT05379985
aThis is not a complete list of eligibility criteria; for more information, please go to ClinicalTrials.gov. bTo view site-level status information, please go to ClinicalTrials.gov.
To potentially enroll in one of the above Revolution Medicines clinical trials, Patients should discuss with their doctor whether they qualify for one of the above Revolution Medicines clinical trials.
These are select clinical trials only. To learn more about all our clinical trials, visit ClinicalTrials.gov. For questions on our clinical trials, please reach out to medinfo@revmed.com or 1-844-2-REVMED (1-844-273-8633).
The safety and efficacy of the agents and/or uses under investigation have not been established.
