670 Participants NeededMy employer runs this trial

Zoldonrasib + Chemotherapy for Pancreatic Cancer

(RASolute 305 Trial)

Recruiting at 8 trial locations
RM
Overseen ByRevolution Medicines Study Director
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Revolution Medicines, Inc.
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 tests a new drug, zoldonrasib, combined with chemotherapy for treating pancreatic cancer. Researchers aim to determine if adding zoldonrasib enhances the effectiveness of chemotherapy compared to chemotherapy alone. Suitable participants have confirmed pancreatic cancer, a specific KRAS gene mutation, and have not received prior advanced cancer treatments. The study compares two groups: one receiving the new drug with chemotherapy, and the other receiving a placebo with chemotherapy. Participants must be able to take oral medications and have a functioning body system to qualify. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do 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 this trial's treatments are likely to be safe?

Previous studies have shown that zoldonrasib is generally safe. Research indicates that most patients found the treatment easy to handle. For example, one study reported a good safety record, consistent with earlier findings in pancreatic cancer cases. Another study found that combining zoldonrasib with another treatment was generally well tolerated at different doses.

The FDA has granted zoldonrasib a special status, recognizing its potential in treating certain cancers. This suggests that the treatment is manageable in terms of safety, making it a noteworthy option to consider. Overall, the evidence supports that zoldonrasib is generally safe for patients, with side effects that are not too severe.12345

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

Unlike the standard treatments for pancreatic cancer, which typically include chemotherapy drugs like 5-Fluorouracil and Gemcitabine, Zoldonrasib stands out due to its novel mechanism of action. Most treatments focus on attacking cancer cells directly, but Zoldonrasib targets specific molecular pathways that drive cancer growth, potentially leading to more effective results. Researchers are excited about Zoldonrasib because it may offer a new way to combat pancreatic cancer, especially when used in combination with traditional chemotherapy, potentially improving outcomes for patients who have limited options.

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

Research has shown that zoldonrasib, a new type of medication, holds promise for treating advanced pancreatic cancer. In this trial, participants in Arm A will receive zoldonrasib combined with chemotherapy, which nearly doubled survival rates compared to standard treatments for this condition. Specifically, 86% of patients taking zoldonrasib experienced a significant drop in a cancer marker called KRAS G12D, with 39% achieving a complete reduction. This indicates that zoldonrasib effectively targets and shrinks cancer cells. These results offer hope for better outcomes in pancreatic cancer treatment when used with chemotherapy.26789

Are You a Good Fit for This Trial?

This trial is for adults with metastatic pancreatic cancer that has a specific KRAS G12D mutation and who have not received prior treatment for advanced disease. Participants need to be in generally good health aside from their cancer.

Inclusion Criteria

Able to take oral medications
I have been diagnosed with pancreatic adenocarcinoma by lab tests.
I am fully active or restricted in physically strenuous activity only.
See 5 more

Exclusion Criteria

I have untreated cancer that has spread to my brain or spinal cord.
I have had major surgery in the last 28 days.
I do not have any conditions that affect how I take or absorb medication.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zoldonrasib or placebo in combination with Investigator choice of chemotherapy (mFFX or GnP)

Up to 5 cycles (each cycle is 28 days)
Regular visits for drug administration and monitoring

Follow-up

Participants are monitored for safety, progression-free survival, and overall survival

Up to approximately 4 years

What Are the Treatments Tested in This Trial?

Interventions

  • 5-Fluorouracil
  • Gemcitabine
  • Irinotecan
  • Leucovorin (Calcium Folinate)
  • Nab-paclitaxel
  • Oxaliplatin
  • Zoldonrasib

Trial Overview

The study compares a new drug called Zoldonrasib plus standard chemotherapy (chosen by the doctor) against a placebo plus the same chemo, as first treatment for this type of pancreatic cancer. Patients are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A: zoldonrasib + chemotherapyExperimental Treatment7 Interventions
Group II: Arm B: placebo + chemotherapyPlacebo Group7 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 Shares New Clinical Results ...

Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%4.

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 ...

First RAS Inhibitor Extends Survival in Previously Treated ...

The once-daily pill essentially doubles overall survival in patients with previously treated metastatic pancreatic cancer compared with standard ...

RAS(ON) Inhibitor Zoldonrasib Is Safe, Shows Early Activity ...

In total, 86% of these patients experienced a KRAS G12D VAF decrease of greater than 50%, and 39% of patients achieved a 100% decrease. “ ...

Study of Zoldonrasib + Chemo of Investigator's Choice vs ...

This is a Phase 3, global, randomized, double-blind study designed to evaluate whether treatment with zoldonrasib in combination with ...

Revolution Medicines

The objective response rate (confirmed or pending confirmation) was 61% (n=11) and the disease control rate was 89% (n=16). “There is a high ...

Zoldonrasib Earns FDA Breakthrough Therapy Designation ...

At the time of analysis, zoldonrasib demonstrated a safety profile that was comparable with previous reports of the agent in pancreatic cancer ...

Study of RMC-9805 in Participants With KRAS G12D- ...

This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.

April 21, 2026

Findings from both trials support daraxonrasib's continued evaluation demonstrating manageable safety and tolerability profiles