Not yet taking people in GermanyPhase 3
Zoldonrasib and daraxonrasib compared with chemotherapy for advanced KRAS G12D pancreatic cancer
Compares two targeted drugs with standard chemotherapy in adults with advanced KRAS G12D pancreatic cancer.
Key facts
- Who runs it
- Revolution Medicines Inc.
- Where
- Berlin, Bochum, Dresden, Frankfurt am Main, Hamburg, Munich, and Ulm, GermanySee the 9 sitesAlso in 8 other countries, 49 sites
- Trial code
- Registry title
- Phase 3 Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC 6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 233 people, planned
- Started
- 2 Oct 2026
- Expected to end
- 1 Mar 2030
- Type of study
- Interventional
- Record updated
- 20 October 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 found metastatic pancreatic adenocarcinoma with a KRAS G12D mutation who have not had treatment for it yet.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Pancreatic adenocarcinoma (including adenosquamous carcinoma) that has spread. Metastatic disease first diagnosed no more than 6 weeks before consent. Disease that can be measured by RECIST v1.1.
- Earlier treatment
- No earlier drug treatment for locally advanced unresectable or metastatic pancreatic cancer. Treatment before or after surgery is allowed if it ended at least 6 months before the metastatic diagnosis.
- Biomarker or test result
- A KRAS G12D mutation shown by a validated test. Tumour tissue as required by the protocol must be available.
Main reasons for not taking part
- Known driver mutations that have approved targeted treatments (for example BRCA1/BRCA2, microsatellite-instability high/mismatch repair deficient, NTRK gene fusion)
- Earlier treatment targeting the MAPK pathway
- Active or known untreated cancer spread to the brain or spinal fluid area (CNS or leptomeningeal disease)
- Conditions that may affect taking or absorbing the study drug
- Major surgery within 28 days before randomization
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- At least 18 years of age (or age greater than or equal to regionally approved age of consent for participation in investigational clinical studies) at the time of signing informed consent form (ICF)
- ECOG performance status (ECOG performance status) 0 or 1
- Definitive histologically or cytologically confirmed pancreatic adenocarcinoma,including adenosquamous carcinoma
- Initial diagnosis of metastatic disease occurring ≤ 6 weeks prior to informed consent
- No prior treatment of pancreatic adenocarcinoma in the locally advanced unresectable or metastatic setting with systemic anticancer therapy • Prior treatment with systemic anticancer therapy given in the neoadjuvant or adjuvant setting, if given in combination with surgical resection, is allowed if completed ≥ 6 months prior to diagnosis of metastatic disease
- Measurable metastatic disease per RECIST v1.1
- Documented KRAS G12D mutation mutations identified by a validated assay
- Availability of protocol‑specified tumour tissue
- Adequate organ function (bone marrow, liver, kidney, coagulation)
Who cannot take part
- Mutation status with previously known driver mutations for which there are approved targeted therapies (eg, BRCA1/BRCA2, microsatellite-instability high/mismatch repair deficient, and NTRK gene fusion)
- Prior therapy with a MAPK-pathway targeted therapy
- Major surgery within 28 days prior to randomization
- Active or known history of untreated central nervous system (CNS) metastatic or leptomeningeal disease
- Any conditions that may affect the ability to take or absorb study drug
- Patient is unable or unwilling to comply with protocol-required 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?
Where in Germany
Also in 8 other countries, 49 sites
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyNot yet recruiting
- Sana Kliniken Berlin-Brandenburg GmbHBerlin, GermanyNot yet recruiting
- Katholisches Klinikum Bochum gGmbHBochum, GermanyNot yet recruiting
- Technische Universitaet DresdenDresden, GermanyNot yet recruiting
- Krankenhaus Nordwest GmbHFrankfurt am Main, GermanyNot yet recruiting
- Norddeutsches Studienzentrum für Innovative Onkologie (NIO)Hamburg, GermanyNot yet recruiting
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, GermanyNot yet recruiting
- LMU Klinikum Muenchen AöRMunich, GermanyNot yet recruiting
- Universitaetsklinikum Ulm AoRUlm, GermanyNot yet recruiting
About the trial
What the trial wants to find out
To compare the efficacy of daraxonrasib plus zoldonrasib versus GnP
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- A Phase 3, Randomized, Open-Label Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Patients with Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma (RASolute 309)
- Plain-language title
- Zoldonrasib and daraxonrasib compared 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 2025-524969-24-00, who can take part
- Record updated
- 20 October 2026