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
Key facts
- Where
- Barcelona, Córdoba, Elche, L'Hospitalet de Llobregat, Madrid, Pamplona, Valencia és Zaragoza, SpanyolországSee the 15 sites
- Phase
- 3. fázis
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?
Where in Spanyolország
- Hospital Clinic de BarcelonaBarcelona, SpanyolországToborzás még nem indult
- Hospital del MarBarcelona, SpanyolországToborzás még nem indult
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországToborzás még nem indult
- Hospital Universitario Reina SofiaCórdoba, SpanyolországToborzás még nem indult
- Hospital Universitario del VinalopoElche, SpanyolországToborzás még nem indult
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpanyolországToborzás még nem indult
- Clinica Universidad de NavarraMadrid, SpanyolországToborzás még nem indult
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországToborzás még nem indult
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországToborzás még nem indult
- Hospital Universitario HM SanchinarroMadrid, SpanyolországToborzás még nem indult
- Hospital Universitario La PazMadrid, SpanyolországToborzás még nem indult
- MD Anderson Cancer CenterMadrid, SpanyolországToborzás még nem indult
- Clínica Universidad de navarraPamplona, SpanyolországToborzás még nem indult
- Hospital Clinico Universitario de ValenciaValencia, SpanyolországToborzás még nem indult
- Hospital Universitario Miguel ServetZaragoza, SpanyolországToborzás még nem indult
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
- EU 2025-524969-24-00
- Record updated
- 2026. október 20.
- Original description
To compare the efficacy of daraxonrasib plus zoldonrasib versus GnPRead full original descriptionShow less
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)
To compare the efficacy of daraxonrasib plus zoldonrasib versus GnP
Inclusion: 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).
Exclusion: 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.