NCT07805954

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3 pancreatic-cancer

Timeline
43mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Aug 2026Apr 2030

Study Start

First participant enrolled

August 28, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

September 8, 2026

Status Verified

August 1, 2026

Enrollment Period

2.5 years

First QC Date

September 1, 2026

Last Update Submit

September 1, 2026

Conditions

Pancreatic CancerPancreatic Cancer MetastaticPDACPDAC - Pancreatic Ductal AdenocarcinomaPancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Adenocarcinoma MetastaticPancreatic AdenocarcinomaPancreatic Adenosquamous Carcinoma

Keywords

Pancreatic CancerPDACPancreatic Ductal AdenocarcinomaRASKRASRAS MutationPancreatic Cancer MetastaticPancreatic Adenocarcinoma MetastaticPancreatic Adenosquamous CarcinomaPancreatic 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 4 years

  • Overall survival (OS)

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

    Up to approximately 4 years

Secondary Outcomes (9)

  • PFS by blinded independent central review (BICR)

    Up to approximately 4 years

  • Objective response rate (ORR)

    Up to approximately 4 years

  • Duration of response (DOR)

    Up to approximately 4 years

  • Incidence of adverse events (AEs)

    Up to approximately 4 years

  • Changes in vital signs

    Up to approximately 4 years

  • +4 more secondary outcomes

Study Arms (2)

Arm A: daraxonrasib + zoldonrasib

EXPERIMENTAL

combination of study drugs

Drug: daraxonrasibDrug: zoldonrasib

Arm B: gemcitabine and nab-paclitaxel

EXPERIMENTAL

chemotherapy

Drug: gemcitabineDrug: nab-paclitaxel

Interventions

daraxonrasibDRUG

oral tablets

Arm A: daraxonrasib + zoldonrasib
gemcitabineDRUG

intravenous (IV) infusion

Arm B: gemcitabine and nab-paclitaxel
nab-paclitaxelDRUG

IV infusion

Arm B: gemcitabine and nab-paclitaxel
zoldonrasibDRUG

oral tablets

Arm A: daraxonrasib + zoldonrasib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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, 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Revolution Medicines Study Director

CONTACT

1-844-2-REVMEDmedinfo@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

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 8, 2026

Study Start

August 28, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

April 1, 2030

Last Updated

September 8, 2026

Record last verified: 2026-08

Locations

US(1)