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 virus (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 Program
Pancreatic ductal adenocarcinoma (PDAC)
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
- 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 previous RAS‑directed therapies
- No major surgery within 4 weeks of starting the trial
NCT06625320
Non-small cell lung cancer (NSCLC)
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
- Confirmed locally advanced or metastatic disease
- Documented RAS mutation status
- No prior therapy with direct RAS‑targeted therapy or docetaxel
- No history of untreated central nervous system metastatic disease
NCT06881784
Non-small cell lung cancer (NSCLC)
RMC-LUNG-101 is a phase 1b/2 study investigating 3 RAS(ON) inhibitors, elironrasib (RMC-6291), zoldonrasib (RMC-9805) and/or daraxonrasib with SOC or zoldonrasib monotherapy, in patients with advanced or metastatic NSCLC or other advanced solid tumors
- 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
NCT06162221
Advanced solid tumors, including PDAC, NSCLC, and colorectal cancer (CRC)
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
- 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
NCT06040541
Advanced solid tumors, including PDAC, NSCLC, and colorectal cancer (CRC)
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
- Male or female 18 years or older
- RAS mutations, including G12D
- No primary central nervous system tumors
- No major surgery within 28 days of first dose
NCT06445062
Advanced solid tumors, including PDAC, NSCLC, and colorectal cancer (CRC)
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 mutant solid tumors, such as NSCLC, CRC, and PDAC
- 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
NCT06128551
Advanced solid tumors, including PDAC, NSCLC, and colorectal cancer (CRC)
RMC-6291-001 is a phase 1/1b study investigating increasing doses of the RAS(ON) inhibitor elironrasib (RMC-6291) in patients with advanced or metastatic solid tumors, including NSCLC, CRC, and PDAC
- 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
NCT05462717
Advanced solid tumors, including PDAC, NSCLC, and colorectal cancer (CRC)
RMC-6236-001 a phase 1/1b study that investigates the RAS(ON) inhibitor daraxonrasib (RMC‑6236) in adult patients with advanced solid tumors, including NSCLC, CRC, and PDAC
- Male or female 18 years or older
- KRAS G12 or RAS mutations
- 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
NCT05379985
aThis is not a complete list of eligibility criteria; for more 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.
