Daraxonrasib for Pancreatic Cancer

(RASolute 303 Trial)

Recruiting at 1 trial location

Overseen By Revolution Medicines Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Revolution Medicines, Inc.

Disqualifiers: Prior systemic therapy, CNS metastases, 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 approximately 2 years

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called daraxonrasib for people with pancreatic cancer. Researchers aim to assess the safety and effectiveness of this drug when used alone or with chemotherapy, compared to standard chemotherapy treatment. The study seeks participants diagnosed with metastatic pancreatic cancer in the last six weeks who have a RAS mutation. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that daraxonrasib is generally well-tolerated. In earlier studies, patients taking daraxonrasib experienced promising results, and safety data confirmed its safe use. The drug did not cause any unexpected side effects beyond those typically associated with cancer treatments.

When combined with chemotherapy drugs gemcitabine and nab-paclitaxel, daraxonrasib's side effects aligned with expectations and did not present unusual or additional risks.

Overall, existing research suggests that daraxonrasib, whether used alone or with chemotherapy, is considered safe based on past studies. However, discussing any concerns or questions with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatment for pancreatic cancer, which typically involves chemotherapy drugs like gemcitabine and nab-paclitaxel, Daraxonrasib offers a novel approach. Researchers are excited about Daraxonrasib because it targets cancer cells in a different way, potentially improving effectiveness. While traditional chemotherapy attacks rapidly dividing cells indiscriminately, Daraxonrasib is designed to specifically target and disrupt cancer cell growth mechanisms. This targeted approach could lead to better outcomes for patients with fewer side effects compared to conventional therapies.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that daraxonrasib may effectively treat pancreatic cancer. In this trial, participants will join different treatment arms. Some will receive daraxonrasib alone, while others will receive it combined with gemcitabine and nab-paclitaxel. Studies found that patients taking daraxonrasib lived for a median of 13.2 months, nearly twice as long as the 6.7 months for those receiving standard chemotherapy. When combined with gemcitabine and nab-paclitaxel, 58% of patients responded well to the treatment, and nearly 90% had their disease under control. These findings suggest that daraxonrasib, whether used alone or with other drugs, could be more effective than standard treatments in helping pancreatic cancer patients live longer and manage their disease. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

* Measurable disease per RECIST v1.1.

I was diagnosed with metastatic disease within the last 6 weeks.

I am at least 18 years old and have agreed to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daraxonrasib monotherapy or daraxonrasib plus gemcitabine and nab-paclitaxel, or gemcitabine and nab-paclitaxel as first-line treatment

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Daraxonrasib
• Gemcitabine
• Nab-paclitaxel

How Is the Trial Designed?

Group I: Arm B: daraxonrasib + gemcitabine and nab-paclitaxel Experimental Treatment 3 Interventions

study drug in combination with chemotherapy

Group II: Arm A: daraxonrasib Experimental Treatment 1 Intervention

study drug

Group III: Arm C: gemcitabine and nab-paclitaxel Active Control 2 Interventions

SOC chemotherapy

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/daraxonrasib-demonstrates-unprecedented-overall-survival-benefit

Daraxonrasib Demonstrates Unprecedented Overall ...

In the overall (intent-to-treat) study population, daraxonrasib demonstrated a median OS of 13.2 months versus 6.7 months for chemotherapy, with ...

2.

onclive.com

onclive.com/view/dr-pant-on-landmark-efficacy-data-with-daraxonrasib-in-previously-treated-metastatic-pdac

Dr Pant on Landmark Efficacy Data With Daraxonrasib in ...

In the intention-to-treat population, patients receiving daraxonrasib achieved a median OS of 13.2 months, nearly doubling the 6.7 months ...

3.

onclive.com

onclive.com/view/dr-wolpin-on-efficacy-with-daraxonrasib-containing-regimens-in-first-line-metastatic-pdac

Dr Wolpin on Efficacy With Daraxonrasib-Containing ...

Landmark analysis at 6 months showed a progression-free survival (PFS) rate of 84% (95% CI, 68%-93%) and an overall survival (OS) rate of 90% ( ...

4.

cancernetwork.com

cancernetwork.com/view/what-median-os-did-daraxonrasib-achieve-in-pretreated-pdac-

What Median OS Did Daraxonrasib Achieve in Pretreated ...

Specifically, the median OS was 13.2 months for those receiving the RAS inhibitor vs 6.7 months for those on standard chemotherapy. This ...

5.

pnas.org

pnas.org/doi/10.1073/pnas.2523039122

RETRACTED: A targeted combination therapy achieves ...

RAS(ON) inhibitors such as daraxonrasib (RMC-6236) have led to significant improvements in survival compared to historical data. Unfortunately, the rapid onset ...

6.

medpagetoday.com

medpagetoday.com/hematologyoncology/othercancers/121148

Safety Data on the Novel Pancreatic Cancer Drug ...

Responses lasted a median 8.2 months, while median progression-free survival (PFS) with the RAS(ON) inhibitor was 8.5 months and overall ...

7.

dana-farber.org

dana-farber.org/newsroom/news-releases/2026/rason-inhibitor-daraxonrasib-shows-promising-results-in-advanced-pancreatic-cancer-phase-12-study

RAS(ON) Inhibitor Daraxonrasib Shows Promising Results ...

The targeted RAS inhibitor daraxonrasib was found to be safe and showed signs of efficacy in a phase 1/2 first-in-human trial in patients ...

8.

mdanderson.org

mdanderson.org/newsroom/research-newsroom/ras-inhibitor-daraxonrasib-phase-1-trial-in-pancreatic-cancer.h00-159855345.html

RAS inhibitor daraxonrasib demonstrates initial anti-tumor ...

These patients have an overall survival of just five to seven months. However, more than 90% of these cancers are driven by RAS mutations, ...