Recruiting
Phase 3

RAS(ON) Inhibitor

Sponsor:

Revolution Medicines, Inc.

Code:

NCT07491445

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

Study Details

Brief summary:

The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

Conditions

Pancreatic Cancer

Pancreatic Cancer Metastatic

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Pancreatic Ductal Adenocarcinoma (PDAC)

Study ID

NCT07491445

Start date

Mar 9, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Jun, 2028

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.
  • Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
  • Documented RAS mutation status, either mutant or wild-type.
  • 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 metastatic setting or prior RAS-targeted therapy in any treatment setting.
  • 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.

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: daraxonrasib

study drug

experimental: Arm B: daraxonrasib + gemcitabine and nab-paclitaxel

study drug in combination with chemotherapy

active comparator: Arm C: gemcitabine and nab-paclitaxel

SOC chemotherapy

Interventions

daraxonrasib

oral tablets

gemcitabine

intravenous (IV) infusion

nab-paclitaxel

IV infusion

Primary outcome measure

  • Progression free survival (PFS) [ Time Frame: Up to approximately 2 years ]
  • Overall survival (OS) [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Revolution Medicines Study Director

1-844-2-REVMEDmedinfo@revmed.com

Locations

Sunnybrook Research Institute

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 1Z5

McGill University - Dept. Oncology Clinical Research Program

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

Revolution Medicines, Inc.

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

  • Pancreatic Cancer
  • PDAC
  • Pancreatic Ductal Adenocarcinoma
  • RAS
  • KRAS
  • NRAS
  • HRAS
  • RAS Wild-Type
  • 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 2026-10-23. This information was provided to ClinicalTrials.gov by Revolution Medicines, Inc. on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.