400 Participants NeededMy employer runs this trial

Zoldonrasib + Daraxonrasib for Pancreatic Cancer

(RASolute 309 Trial)

Recruiting at 5 trial locations
RM
Overseen ByRevolution Medicines Study Director
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination therapy using two investigational drugs, daraxonrasib and zoldonrasib, for treating pancreatic cancer. The main goal is to determine if these drugs are more effective than standard chemotherapy. Suitable candidates for this trial have advanced-stage pancreatic cancer that hasn't been treated yet and possess a specific mutation known as KRAS G12D.

As a Phase 3 trial, this study represents the final step before FDA approval, providing patients an opportunity to access potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

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 this trial's treatments are likely to be safe?

Research has shown that the combination of daraxonrasib and zoldonrasib for pancreatic cancer has a manageable safety profile. Early studies indicate that zoldonrasib, when combined with other treatments, is generally safe and well-tolerated by most patients. However, about one-third of patients taking daraxonrasib experienced serious treatment-related side effects, which can be managed.

The chemotherapy combination of gemcitabine and nab-paclitaxel is already approved for treating pancreatic cancer, and its safety is well understood. While chemotherapy can cause side effects like tiredness, nausea, and hair loss, these are generally expected. In summary, both treatment options have safety data suggesting they are tolerable, with anticipated side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about daraxonrasib and zoldonrasib for pancreatic cancer because they offer a novel approach compared to the standard chemotherapy options like gemcitabine and nab-paclitaxel. Daraxonrasib and zoldonrasib are designed to work together to target cancer cells more precisely, potentially enhancing effectiveness and reducing side effects. Unlike traditional treatments that broadly attack rapidly dividing cells, this combination specifically disrupts cancer cell growth mechanisms, which might lead to improved outcomes for patients.

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

Research has shown that the combination of daraxonrasib and zoldonrasib, which participants in this trial may receive, holds promise for treating pancreatic cancer. Studies have found that 50% of patients respond positively to this treatment, with an average of 7.6 months without disease progression. In comparison, another treatment option in this trial, gemcitabine and nab-paclitaxel (a type of chemotherapy), has improved survival rates for patients with advanced pancreatic cancer. Specifically, this treatment has resulted in an average survival time of 11.1 months and a 59% increase in the number of patients living for at least one year compared to older treatments. This trial tests both treatment combinations to determine which provides better results for patients.678910

Are You a Good Fit for This Trial?

This trial is for adults with advanced pancreatic cancer that has spread (metastatic) and has a specific KRAS G12D gene mutation. Participants must not have received prior treatment for their metastatic disease.

Inclusion Criteria

My cancer has a confirmed KRAS G12D mutation.
My bone marrow, liver, and kidneys are working well.
I was diagnosed with metastatic disease within the last 6 weeks.
See 5 more

Exclusion Criteria

My cancer has a known mutation with approved targeted treatments.
My pancreatic cancer is not adenocarcinoma.
My tumor did not start in the pancreas.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either daraxonrasib + zoldonrasib or gemcitabine and nab-paclitaxel as first-line treatment

Up to approximately 4 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
  • Zoldonrasib

Trial Overview

The study compares two new drugs, zoldonrasib and daraxonrasib taken together, against standard chemotherapy drugs gemcitabine and nab-paclitaxel. Patients are randomly assigned to one of the treatments as their first therapy.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Arm B: gemcitabine and nab-paclitaxelExperimental Treatment2 Interventions
Group II: Arm A: daraxonrasib + zoldonrasibExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Revolution Medicines, Inc.

Lead Sponsor

Trials
14
Recruited
4,500+

Citations

Revolution Medicines Presents Phase 1/2 Clinical Data for ...

The zoldonrasib plus daraxonrasib combination demonstrated compelling antitumor activity. Median progression-free survival with a 6-month OS ...

Zoldonrasib Combos, Including With Daraxonrasib, Yield ...

The results presented at ESMO GI demonstrate compelling proof-of-concept for 2 zoldonrasib- was 90% (95% CI, 74%-98%). The median PFS was 7.6 ...

Zoldonrasib combos show responses in KRAS G12D ...

the 5-year survival rate is approximately 3% The zoldonrasib plus daraxonrasib combination was associated with an ORR of 50% in 30 patients who ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/42223072/

Daraxonrasib or Chemotherapy in Previously Treated ...

The median overall survival in the RAS G12 population was 13.2 months with daraxonrasib and 6.6 months with chemotherapy, and the median overall ...

Final Results of the Daraxonrasib Trial Are Unprecedented

The six-month progression-free survival rates were 58.7 percent for daraxonrasib and 31.7 percent for chemotherapy. The respective overall ...

Daraxonrasib shows promise for metastatic pancreatic ...

The new oral medicine doubled the median overall survival time to 13.2 months, compared to only 6.6 months for patients on standard intravenous ...

Revolution Medicines reports encouraging early data for ...

Revolution Medicines has reported early Phase I/II data for zoldonrasib-based combinations in. Revolution Medicines' daraxonrasib doubles survival in Phase III ...

Daraxonrasib and Beyond: Pan‐RAS Inhibition, Resistance ...

median overall survival was 13.2 months with daraxonrasib and 6.6 months with chemotherapy. Median progression‐free survival was 7.3 and 3.5 months,

zoldonrasib (RMC-9805) News

Zoldonrasib + daraxonrasib showed manageable safety and compelling preliminary efficacy in 2L+ KRAS G12D mPDAC. These results support initiation of RASolute ...

Zoldonrasib + Chemotherapy for Pancreatic Cancer

Previous studies have shown that zoldonrasib is generally safe. Research indicates that most patients found the treatment easy to handle.