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 )

Official record

Identifier

NCT07621718

Recruiting locations

countries

United StatesUnited Kingdom

Interventions studied

ZoldonrasibPlaceboOxaliplatinLeucovorin (Calcium Folinate)5-FluorouracilIrinotecanGemcitabine (GEM)Nab-paclitaxel

Lead sponsor

Revolution Medicines, Inc.

Target enrolment

670 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Jun 2, 2026

Last updated on the registry

Sep 28, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* 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 Criteria:

* 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
* Active or known history of untreated central nervous system metastatic disease.
* Any conditions that may affect the ability to take or absorb study drug.
* Major surgery within 28 days prior to randomization.
* Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Indexed under

Pancreatic Cancer