Recruiting
Phase 3

Daraxonrasib & Zoldonrasib

Sponsor:

Revolution Medicines, Inc.

Code:

NCT07805954

Conditions

Pancreatic Cancer

Pancreatic Cancer Metastatic

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

daraxonrasib

gemcitabine

nab-paclitaxel

zoldonrasib

Study Details

Brief summary:

The purpose of this study is to evaluate the efficacy of combination therapy with two investigational RAS(ON) inhibitors (daraxonrasib and zoldonrasib) compared to chemotherapy.

Conditions

Pancreatic Cancer

Pancreatic Cancer Metastatic

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Pancreatic Ductal Adenocarcinoma (PDAC)

Study ID

NCT07805954

Start date

Aug 28, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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, including adenosquamous carcinoma, not previously treated in the locally advanced unresectable or metastatic setting.
  • No prior treatment in the locally advanced unresectable or metastatic setting
  • Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
  • Documented KRAS G12D mutation status.
  • Measurable disease per RECIST v1.1.
  • Adequate organ function (bone marrow, liver, kidney, coagulation).

Exclusion Criteria:

  • Mutation status with known driver mutations for which there are approved targeted therapies.
  • Acinar cell carcinoma, pancreatic neuroendocrine tumors, tumors involving islet cells or islet cell neoplasms, and other non-adenocarcinoma pancreatic malignancies.
  • Tumors determined to originate from non-pancreatic primary sites.
  • Prior treatment with MAPK-pathway targeted therapy or administration of RAS-targeted vaccine in the metastatic setting.
  • Active or known history of untreated central nervous system metastatic or leptomeningeal 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.
  • Additional inclusion \& exclusion criteria may apply.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: daraxonrasib + zoldonrasib

combination of study drugs

experimental: Arm B: gemcitabine and nab-paclitaxel

chemotherapy

Interventions

daraxonrasib

oral tablets

gemcitabine

intravenous (IV) infusion

nab-paclitaxel

IV infusion

zoldonrasib

oral tablets

Primary outcome measure

  • Progression free survival (PFS) [ Time Frame: Up to approximately 4 years ]
  • Overall survival (OS) [ Time Frame: Up to approximately 4 years ]

Central Contacts and Locations

Central contacts

Revolution Medicines Study Director

1-844-2-REVMEDmedinfo@revmed.com

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Cheyenne Schneider

813-745-5166Cheyenne.Schneider@moffitt.org

More Information

Sponsor

Revolution Medicines, Inc.

Last update posted

Sep 8, 2026

Last verified

Aug, 2026

Keywords

  • Pancreatic Cancer
  • PDAC
  • Pancreatic Ductal Adenocarcinoma
  • RAS
  • KRAS
  • RAS Mutation
  • Pancreatic Cancer Metastatic
  • Pancreatic Adenocarcinoma Metastatic
  • Pancreatic Adenosquamous Carcinoma
  • Pancreatic Adenocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Revolution Medicines, Inc. on 2026-09-08.