Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

NCT07491445 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: RMC-6236-303
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 5

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 Adenocarcinoma Metastatic; Pancreatic Adenocarcinoma; Pancreatic Ductal Adenocarcinoma (PDAC); Pancreatic Adenosquamous Carcinoma

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

Outcome Measures

Primary Outcomes (2)

• Progression free survival (PFS)

  PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator.

  Up to approximately 2 years

• Overall survival (OS)

  OS is defined as the time from randomization until death from any cause.

  Up to approximately 2 years

Secondary Outcomes (8)

• Objective response rate (ORR)

  Up to approximately 2 years

• Duration of response (DOR)

  Up to approximately 2 years

• Concentration of daraxonrasib in Arm A and B

  Up to Cycle 5 Day 1 (each cycle is 28 days)

• Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26)

  Up to approximately 2 years

• Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

  Up to approximately 2 years

Study Arms (3)

Arm A: daraxonrasib

EXPERIMENTAL

study drug

Drug: daraxonrasib

Arm B: daraxonrasib + gemcitabine and nab-paclitaxel

EXPERIMENTAL

study drug in combination with chemotherapy

Drug: daraxonrasib; Drug: gemcitabine; Drug: nab-paclitaxel

Arm C: gemcitabine and nab-paclitaxel

ACTIVE COMPARATOR

SOC chemotherapy

Drug: gemcitabine; Drug: nab-paclitaxel

Interventions

daraxonrasib DRUG

oral tablets

Arm A: daraxonrasib; Arm B: daraxonrasib + gemcitabine and nab-paclitaxel

gemcitabine DRUG

intravenous (IV) infusion

Arm B: daraxonrasib + gemcitabine and nab-paclitaxel; Arm C: gemcitabine and nab-paclitaxel

nab-paclitaxel DRUG

IV infusion

Arm B: daraxonrasib + gemcitabine and nab-paclitaxel; Arm C: gemcitabine and nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Revolution Medicines, Inc.: lead

Study Sites (5)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89052, United States

RECRUITING

Taylor Cancer Research Center

Maumee, Ohio, 43537, United States

RECRUITING

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Revolution Medicines Study Director

CONTACT

1-844-2-REVMED; medinfo@revmed.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 24, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

US (5)