Zoldonrasib added to chemotherapy for metastatic pancreatic cancer with a KRAS G12D mutation
Tests zoldonrasib plus chemotherapy against placebo plus chemotherapy in metastatic pancreatic adenocarcinoma.
Plain-language title generated from the registry record
Registry title: Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Key facts
- Where
- Atlanta, Baltimore, Boston, Chicago, Durham, East Brunswick, Gainesville, Houston, Jacksonville, Nashville, New Brunswick, New Haven, New York, Phoenix, Rochester, Tampa, and Tucson, United StatesSee the 18 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT07621718, who can take part
Where in United States
- Piedmont Cancer InstituteAtlanta, United StatesTaking people
- Piedmont HealthcareAtlanta, United StatesTaking people
- Johns Hopkins UniversityBaltimore, United StatesTaking people
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- University of Chicago Medical CenterChicago, United StatesTaking people
- Duke Cancer CenterDurham, United StatesTaking people
- Astera Cancer CareEast Brunswick, United StatesTaking people
- University of FloridaGainesville, United StatesTaking people
- University of Texas - MD Anderson Cancer CenterHouston, United StatesTaking people
- Mayo Clinic FloridaJacksonville, United StatesTaking people
- Vanderbilt-Ingram Cancer CenterNashville, United StatesTaking people
- Rutgers Cancer UniversityNew Brunswick, United StatesTaking people
- Yale UniversityNew Haven, United StatesTaking people
- Columbia University Irving Medical CenterNew York, United StatesTaking people
- Mayo Clinic - ArizonaPhoenix, United StatesTaking people
- Mayo Clinic - RochesterRochester, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesTaking people
- The University of Arizona Cancer Center-North CampusTucson, United StatesTaking people
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?
Trial details
- Who runs it
- Revolution Medicines, Inc.
- Trial code
- NCT07621718
- Record updated
- 6 November 2026
- Original description
The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.Read full original descriptionShow less
RASolute 305: 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
The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.
Inclusion: At least 18 years old and has provided informed consent; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Histologically or cytologically confirmed pancreatic adenocarcinoma; Diagnosis of metastatic disease ≤ 6 weeks prior to screening; Documented KRAS G12D mutation status; Measurable disease per RECIST v1.1; Adequate organ function (bone marrow, liver, kidney, coagulation); Able to take oral medications.
Exclusion: Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting; Prior systemic RAS-targeted therapy any time prior to randomization; Presence of other known driver mutations with approved targeted therapies; Major surgery within 28 days prior to randomization; Active or known history of untreated central nervous system metastatic 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.