newwin
Luciann Nguyen
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NCT07621718phase 3recruiting

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 )

Revolution Medicines, Inc.

ClinicalTrials.gov
670
Enrollment · estimated
1
Countries · 6 sites
2028-12
Primary completion
19 days ago
Record updated
Commercial relevance

Trial record references molecular eligibility required, central lab testing referenced.

Molecular eligibility requiredCentral lab testing
Biomarker requirement language
  • Documented KRAS G12D mutation status.
Change timeline

No changes detected yet. The first refresh records a baseline snapshot; subsequent refreshes generate field-level changes.

Signals from this trial
  • New trial
    64/100
    Opportunity

    New phase 3 trial NCT07621718 posted by Revolution Medicines, Inc.: "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 )".

    ClinicalTrials.gov record updated 18 days ago.

Eligibility — raw, for validation
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.