Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Last updated: September 9, 2025
Sponsor: Revolution Medicines, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Adenocarcinoma

Cancer

Digestive System Neoplasms

Treatment

nab-paclitaxel

5-fluorouracil

Oxaliplatin

Clinical Study ID

NCT06625320
RMC-6236-302
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.

Eligibility Criteria

Inclusion

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 PDAC with metastatic disease.

  • Measurable disease per RECIST 1.1.

  • Adequate organ function (bone marrow, liver, kidney, coagulation)

  • Documented RAS mutation status, either mutant or wild-type. RAS mutations defined asnonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, orQ61).

  • Able to take oral medications.

Exclusion

Exclusion Criteria:

  • Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).

  • History of or known central nervous system metastatic disease.

  • Any conditions that may affect the ability to take or absorb study treatment

  • Major surgery within 4 weeks prior to randomization.

  • Patient is unable or unwilling to comply with protocol-required study visits orprocedures

Study Design

Total Participants: 460
Treatment Group(s): 8
Primary Treatment: nab-paclitaxel
Phase: 3
Study Start date:
October 16, 2024
Estimated Completion Date:
December 31, 2027

Study Description

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with RMC-6236 will improve progression free survival (PFS) or overall survival (OS) compared to Investigator's choice of standard of care chemotherapy in patients with metastatic PDAC who were previously treated with one prior line of therapy with 5-fluorouracil (5-FU) based or gemcitabine-based regimen.

Patients will be randomized in a 1:1 ratio to receive RMC-6236 (Arm A) or Investigator's choice of standard of care chemotherapy (Arm B).

Connect with a study center

  • Institut Paoli Calmettes

    Marseille, 13009
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille 2995469, 13009
    France

    Site Not Available

  • Centre Eugene Marquis

    Rennes, 35042
    France

    Site Not Available

  • Centre Eugene Marquis

    Rennes 2983990, 35042
    France

    Site Not Available

  • Hopital Paul Brousse

    Val de Marne, 94804
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

  • Hopital Paul Brousse

    Villejuif, 94804
    France

    Site Not Available

  • Gustave Roussy

    Villejuif 2968705, 94805
    France

    Site Not Available

  • Hopital Paul Brousse

    Villejuif 2968705, 94804
    France

    Site Not Available

  • Charité Universitätsmedizin, Campus Berlin Mitte

    Berlin, 13353
    Germany

    Site Not Available

  • Charité Universitätsmedizin, Campus Berlin Mitte

    Berlin 2950159, 13353
    Germany

    Active - Recruiting

  • Nationales Centrum fur

    Heidelberg, 69120
    Germany

    Site Not Available

  • Nationales Centrum fur

    Heidelberg 2907911, 69120
    Germany

    Active - Recruiting

  • Universitatsklinikum Ulm, Zentru

    München 2867711, 81377
    Germany

    Active - Recruiting

  • Universitatsklinikum Ulm

    Ulm 2820256, 89081
    Germany

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan,
    Italy

    Site Not Available

  • IEO-Istituto Europeo di Oncologia

    Milan,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan 3173435,
    Italy

    Site Not Available

  • IEO-Istituto Europeo di Oncologia

    Milan 3173435,
    Italy

    Site Not Available

  • IOV-Istituto Oncologico

    Padova, 35128
    Italy

    Site Not Available

  • IOV-Istituto Oncologico

    Padua 3171728, 35128
    Italy

    Site Not Available

  • Azienda Ospedaliera

    Pisa, 56126
    Italy

    Site Not Available

  • Azienda Ospedaliera

    Pisa 3170647, 56126
    Italy

    Site Not Available

  • National Cancer Center

    Chiba, 277-8577
    Japan

    Site Not Available

  • National Cancer Center

    Chiba 2113015, 277-8577
    Japan

    Active - Recruiting

  • Aichi Cancer Center

    Nagoya, 4648681
    Japan

    Site Not Available

  • Aichi Cancer Center

    Nagoya 1856057, 4648681
    Japan

    Active - Recruiting

  • Osaka International Cancer

    Osaka, 541-8567
    Japan

    Site Not Available

  • Osaka International Cancer

    Osaka 1853909, 541-8567
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of JFCR

    Tokyo, 135-8550
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Tokyo, 104-0045
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of JFCR

    Tokyo 1850147, 135-8550
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Tokyo 1850147, 104-0045
    Japan

    Active - Recruiting

  • Kanagawa Cancer Center

    Yokohama, 241-8515
    Japan

    Site Not Available

  • Kanagawa Cancer Center

    Yokohama 1848354, 241-8515
    Japan

    Active - Recruiting

  • Pan-American Center for Oncology Trials

    San Juan, 00907
    Puerto Rico

    Site Not Available

  • Pan-American Center for Oncology Trials

    San Juan 4568127, 00907
    Puerto Rico

    Site Not Available

  • Hospital Unversitari

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Unversitari

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • Hospital Clinico de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Clinico de Valencia

    Valencia 2509954, 46010
    Spain

    Site Not Available

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Mayo Clinic

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Mayo Clinic Cancer Center - Phoenix

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Banner MD Anderson Cancer Center

    Gilbert 5295903, Arizona 5551752 85234
    United States

    Site Not Available

  • Mayo Clinic Cancer Center - Phoenix

    Phoenix 5308655, Arizona 5551752 85054
    United States

    Site Not Available

  • City of Hope-Duarte

    Duarte, California 91010
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • UC San Diego Health Moores Cancer Center

    San Diego, California 92037
    United States

    Site Not Available

  • Mission Hall UCSF

    San Francisco, California 94158
    United States

    Site Not Available

  • City of Hope-Duarte

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • UCLA

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • UC San Diego Health Moores Cancer Center

    San Diego 5391811, California 5332921 92037
    United States

    Site Not Available

  • Mission Hall UCSF

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • Rocky Mountain Cancer

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Rocky Mountain Cancer

    Aurora 5412347, Colorado 5417618 80012
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Mayo Clinic Cancer Center - Florida

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Cancer Care Centers of Brevard Inc

    Palm Bay, Florida 32909
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Mayo Clinic Cancer Center - Florida

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Cancer Care Centers of Brevard Inc

    Palm Bay 4167499, Florida 4155751 32909
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • The Queen's Medical Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • The Queen's Medical Center

    Honolulu 5856195, Hawaii 5855797 96813
    United States

    Site Not Available

  • The University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • The University of Chicago Medical Center

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit 4990729, Michigan 5001836 48201
    United States

    Site Not Available

  • Mayo Clinic Cancer Center - Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic Cancer Center - Rochester

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10022
    United States

    Active - Recruiting

  • NYU Lagone Health

    New York, New York 10016
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo 5110629, New York 5128638 14263
    United States

    Site Not Available

  • Columbia University Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10022
    United States

    Site Not Available

  • NYU Lagone Health

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Duke University Medical Center

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Stephenson Cancer Center

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Abramson Cancer Center Clinical Research Unit

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Abramson Cancer Center Clinical Research Unit

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Site Not Available

  • Sarah Cannon Research Institute (Tennessee)

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon Research Institute (Tennessee)

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Texas Oncology Sammons

    Dallas, Texas 75246
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Oncology - Central South

    Irving, Texas 75063
    United States

    Site Not Available

  • Texas Oncology Sammons

    Dallas 4684888, Texas 4736286 75246
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Texas Oncology - Central South

    Irving 4700168, Texas 4736286 75063
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle 5809844, Washington 5815135 98109
    United States

    Site Not Available

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