Daraxonrasib for Pancreatic Cancer

(RASolute 304 Trial)

Recruiting at 2 trial locations

Overseen By Revolution Medicines Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Revolution Medicines, Inc.

Must not be taking: RAS-targeted therapy

Disqualifiers: Surgery, Absorption issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 years

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, Daraxonrasib, for individuals with pancreatic cancer to determine if it is more effective than regular check-ups. The trial targets those who have undergone surgery to remove the cancer and completed chemotherapy within the last 12 weeks. Participants should have a specific type of pancreatic cancer with a RAS mutation and must be able to take pills orally. The study will compare the effects of the new drug against regular observation to determine which is more effective. Meeting these conditions could provide an opportunity to try a promising new treatment. As a Phase 3 trial, this treatment represents the final step before FDA approval, offering access to a potentially groundbreaking therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Daraxonrasib is likely to be safe for humans?

Previous studies have shown that daraxonrasib was generally well tolerated by patients with RAS mutations, including those with pancreatic cancer. Research indicates that when combined with another treatment (GnP), daraxonrasib was safe for most patients, with manageable side effects. One study found that daraxonrasib was effective against tumors and safe for pancreatic cancer patients at a 300 mg dose. These findings suggest it is a promising option with a good safety record for those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer?

Researchers are excited about Daraxonrasib for pancreatic cancer because it offers a novel approach compared to traditional treatments like chemotherapy. Most current treatments aim to kill cancer cells directly, but Daraxonrasib works differently by targeting specific molecular pathways that drive cancer growth. This targeted action can potentially lead to fewer side effects and improve the precision of the treatment. Its unique mechanism of action brings hope for better outcomes in a disease that is notoriously difficult to treat.

What evidence suggests that Daraxonrasib might be an effective treatment for pancreatic cancer?

Research has shown that daraxonrasib, which participants in this trial may receive, could be a promising treatment for pancreatic cancer, especially for patients with RAS mutations. In earlier studies, patients taking daraxonrasib lived longer and experienced fewer side effects than expected. The drug demonstrated strong effects against tumors, with 47% of patients seeing their tumors shrink or disappear, and 89% experiencing no cancer growth. These findings suggest that daraxonrasib could be an effective treatment option for people with pancreatic cancer, particularly those with certain genetic mutations. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for patients who have had surgery to remove pancreatic ductal adenocarcinoma (PDAC) and are now in the observation phase. Specific eligibility criteria details were not provided, so interested individuals should contact the study organizers for more information.

Inclusion Criteria

I can take pills by mouth.

I am over 18 and have agreed to participate.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have been treated with drugs targeting RAS before.

I have no conditions that affect my ability to take or absorb medication.

I have not had major surgery in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daraxonrasib or undergo standard of care observation

Up to 5 years

Follow-up

Participants are monitored for disease-free survival and overall survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Daraxonrasib

Trial Overview The trial is testing Daraxonrasib, a new inhibitor targeting RAS(ON), against standard post-surgery observation with no additional treatment in patients with resected PDAC to assess its safety and effectiveness.

How Is the Trial Designed?

Group I: daraxonrasib Experimental Treatment 1 Intervention

study drug

Group II: SOC Observation Active Control 1 Intervention

Patients randomized to the comparator control arm will receive SOC observation.

Who Is Running the Clinical Trial?

Revolution Medicines, Inc.

Lead Sponsor

Trials

14

Recruited

4,500+

Citations

1. ir.revmed.com ir.revmed.com/news-releases/news-release-details/revolution-medicines-shares-new-clinical-results-supporting

Revolution Medicines Shares New Clinical Results ... The median overall survival (OS) was 13.1 (95% CI, 10.9 – NE) and 15.6 months (95% CI, 10.9 – NE). Median follow-up was 16.7 months. RASolute ...

2. digestivecancers.eu digestivecancers.eu/key-takeaways-from-esmo-gi-2025-on-pancreatic-cancer/

Key Takeaways from ESMO GI 2025 on Pancreatic Cancer In earlier studies, daraxonrasib showed encouraging results, i.e., patients lived longer and had fewer side effects than expected.

3. onclive.com onclive.com/view/daraxonrasib-demonstrates-efficacy-potential-to-inhibit-major-ras-on-variants-in-ras-pdac

Daraxonrasib Demonstrates Efficacy, Potential to Inhibit ... Daraxonrasib demonstrated significant antitumor activity and safety in RAS-mutated PDAC patients, with notable PFS and ORR at a 300 mg dose.

4. targetedonc.com targetedonc.com/view/daraxonrasib-earns-fda-orphan-drug-designation-in-pancreatic-cancer

Daraxonrasib Earns FDA Orphan Drug Designation in ... The FDA designates daraxonrasib as an orphan drug for pancreatic cancer, targeting RAS mutations with promising trial results.

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/revolution-medicines-daraxonrasib-phase-i-results-2/

Revolution's daraxonrasib moves to Phase III after PDAC ... In the monotherapy arm, patient ORR was 47%, while DCR was 89% after a median follow-up of 9.3 months – though the biotech will need to collect ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06625320

Phase 3 Study of Daraxonrasib (RMC-6236) in Patients ... The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment. Detailed ...

7. oncodaily.com oncodaily.com/oncolibrary/rasolute-303-daraxonrasib-in-1l-mts-pdac

RASolute 303 Trial Evaluates Daraxonrasib in First-Line ... Among 38 evaluable patients, the objective response rate (ORR) reached 47% and the disease control rate (DCR) 89%, with a median follow-up of ...