Phase 3 Study of Investigator Choice of Chemotherapy with or without Zoldonrasib as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma
Key facts
- Where
- Berlin, Bochum, Dresden, Frankfurt am Main, Hamburg, Heidelberg, Heilbronn, Munich és Ulm, NémetországSee the 12 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?
- Which describes how well you can do daily activities?
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországToborzás még nem indult
- Sana Kliniken Berlin-Brandenburg GmbHBerlin, NémetországToborzás még nem indult
- Katholisches Klinikum Bochum gGmbHBochum, NémetországToborzás még nem indult
- Technische Universitaet DresdenDresden, NémetországToborzás még nem indult
- Krankenhaus Nordwest GmbHFrankfurt am Main, NémetországToborzás még nem indult
- Asklepios Kliniken Hamburg GmbHHamburg, NémetországToborzás még nem indult
- Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative OnkologieHamburg, NémetországToborzás még nem indult
- Universitaetsklinikum Heidelberg AöRHeidelberg, NémetországToborzás még nem indult
- SLK-Kliniken Heilbronn GmbHHeilbronn, NémetországToborzás még nem indult
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, NémetországToborzás még nem indult
- LMU Klinikum Muenchen AöRMunich, NémetországToborzás még nem indult
- Universitaetsklinikum Ulm AoRUlm, NémetországToborzás 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 2025-524928-21-00
- Record updated
- 2026. szeptember 25.
- Original description
To compare the efficacy of zoldonrasib plus Investigator choice of chemotherapy (mFFX or GnP) versus placebo plus Investigator choice of chemotherapy (mFFX or GnP)Read full original descriptionShow less
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)
To compare the efficacy of zoldonrasib plus Investigator choice of chemotherapy (mFFX or GnP) versus placebo plus Investigator choice of chemotherapy (mFFX or GnP)
Inclusion: 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.
Exclusion: 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.