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Taking peoplePhase 3

Tests zoldonrasib with chemotherapy for advanced KRAS G12D pancreatic cancer

Tests zoldonrasib plus chemotherapy against placebo plus chemotherapy in adults with advanced pancreatic cancer.

Key facts

Who runs it
Revolution Medicines Inc.
Where
Herlev, DenmarkSee the siteAlso in 11 other countries, 63 sites
Registry title
Phase 3 Study of Investigator Choice of Chemotherapy with or without Zoldonrasib as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma
Status
Recruiting
Phase
Phase 3
People taking part
281 people, planned
Started
12 Oct 2026
Expected to end
30 Nov 2029
Type of study
Interventional
Record updated
25 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed pancreatic adenocarcinoma that has spread (metastatic) and carries a KRAS G12D mutation. It tests chemotherapy with zoldonrasib or with placebo.

Age
18 years or older (or the legal age of consent)
Sex
All sexes can join.
Disease stage
Metastatic pancreatic adenocarcinoma, newly diagnosed within 6 weeks or less before screening. At least one lesion that can be measured (RECIST 1.1). ECOG performance status of 0 or 1.
Earlier treatment
No earlier systemic therapy for unresectable locally advanced or metastatic pancreatic adenocarcinoma. No earlier RAS-targeted therapy (including KRAS inhibitors) or MAPK pathway targeted drugs.
Biomarker or test result
A KRAS G12D mutation confirmed by a validated test.

Main reasons for not taking part

  • Other known driver gene changes that have approved targeted treatment (for example BRAF V600E, MSI-high/dMMR, NTRK fusions)
  • Pancreatic cancers that are not adenocarcinoma (for example neuroendocrine tumors, acinar cell carcinoma)
  • Brain or CNS spread that is untreated or causes symptoms, or leptomeningeal disease
  • Active infections that are not controlled, including hepatitis B, hepatitis C or HIV
  • Major surgery within 28 days before randomization

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Adult patients (≥18 years or legal age of consent)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically of cytologically confirmed pancreatic adenocarcinoma
  • Metastatic disease, newly diagnosed within ≤6 weeks prior to screening
  • Documented KRAS G12D mutations identified by a validated assay
  • At least one measurable lesion per RECIST version 1.1
  • Adequate organ function (hematologic, hepatic and renal)
  • Able to take oral medications

Who cannot take part

  • Prior systemic therapy for unresectable locally advanced or metastatic pancreatic adenocarcinoma
  • Prior treatment with RAS-targeted therapies (including KRAS inhibitors) or MAPK pathway targeted agents
  • Presence of other known actionable oncogenic driver alterations for which approved targeted therapies are available (eg BRAF V600E, MSI-high/dMMR, NTRK fusions)
  • Major surgery within 28 days prior to randomization
  • Non-adenocarcinoma pancreatic malignancies (eg neuroendocrine tumors, acinar cell carcinoma)
  • Untreated or symptomatic central nervous system metastases or leptomeningeal disease
  • Clinically significant uncontrolled comorbidities (including cardiovascular, pulmonary, or gastrointestinal conditions that may affect safety or drug absorption)
  • Active uncontrolled infections, including hepatitis B, hepatitis C, or HIV not meeting protocol-defined control criteria
  • Noncompliance with study visits or procedures

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Has a test of your tumor found a change in the KRAS gene called G12D?
  • Which describes how well you can do daily activities?

Where in Denmark

Also in 11 other countries, 63 sites

  • Region HovedstadenHerlev, DenmarkNot yet recruiting

About the trial

What the trial wants to find out

To compare the efficacy of zoldonrasib plus Investigator choice of chemotherapy (mFFX or GnP) versus placebo plus Investigator choice of chemotherapy (mFFX or GnP)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (modified FOLFIRINOX or Gemcitabine plus Nab-paclitaxel) with or without Zoldonrasib (RMC-9805) as First-line Treatment in Patients with Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma (RASolute 305)
Plain-language title
Tests zoldonrasib with chemotherapy for advanced KRAS G12D pancreatic cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2025-524928-21-00, who can take part
Record updated
25 September 2026