A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Last updated: February 6, 2026
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

1

Condition

Solid Tumors

Neoplasms

Adenocarcinoma

Treatment

FOLFOX

GEMNabP

INCB161734

Clinical Study ID

NCT06179160
INCB161734-101
2023-507091-47-00
  • Ages > 18
  • All Genders

Study Summary

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years old.

  • Locally advanced or metastatic solid tumor with KRAS G12D mutation.

  • For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on priorstandard treatment, intolerance to or ineligibility for standard treatment, declinedavailable therapies that are known to confer clinical benefit, or no standardavailable treatment to improve the disease outcome.

  • Cohort specific requirements aas defined in the protocol.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion

Exclusion Criteria:

  • Prior treatment with any KRAS G12D inhibitor

  • Known additional invasive malignancy within 1 year of the first dose of study drug

  • History of organ transplant, including allogeneic stem cell transplantation

  • Significant, uncontrolled medical condition

  • History or presence of an ECG abnormality

  • Inadequate organ function

Other protocol-defined Inclusion/Exclusion Criteria may apply

Study Design

Total Participants: 710
Treatment Group(s): 8
Primary Treatment: FOLFOX
Phase: 1
Study Start date:
January 04, 2024
Estimated Completion Date:
January 01, 2027

Connect with a study center

  • Chris Obrien Lifehouse

    Camperdown, New South Wales 02050
    Australia

    Site Not Available

  • St Vincent'S Hospital Sydney

    Darlinghurst, New South Wales 02010
    Australia

    Site Not Available

  • St. Vincent'S Hospital Sydney

    Darlinghurst, New South Wales 02010
    Australia

    Site Not Available

  • Chris Obrien Lifehouse

    Camperdown 2172563, New South Wales 2155400 02050
    Australia

    Active - Recruiting

  • St Vincent'S Hospital Sydney

    Darlinghurst 2169378, New South Wales 2155400 02010
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 03004
    Australia

    Site Not Available

  • Peter Maccallum Cancer Centre

    North Melbourne, Victoria 3051
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne 2158177, Victoria 2145234 03004
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    North Melbourne 2154912, Victoria 2145234 3051
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia 06009
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands 2064874, Western Australia 2058645 06009
    Australia

    Active - Recruiting

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01200
    Belgium

    Site Not Available

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels 2800866, 01200
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Antwerpen (Uza)

    Edegem, 02650
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Antwerpen (Uza)

    Edegem 2799007, 02650
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis (Uz) Leuven

    Leuven, 03000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis (Uz) Leuven

    Leuven 2792482, 03000
    Belgium

    Active - Recruiting

  • The Ottawa Hospital Cancer Center

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Princess Margaret Cancer Center

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • The Ottawa Hospital Cancer Center

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Center

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Active - Recruiting

  • Centre Leon Berard

    Lyon, 69373
    France

    Site Not Available

  • Centre Leon Berard

    Lyon 2996944, 69373
    France

    Active - Recruiting

  • Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

    Toulouse, 31059
    France

    Site Not Available

  • Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

    Toulouse 2972315, 31059
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif 2968705, 94805
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif Cedex, 94805
    France

    Site Not Available

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133
    Italy

    Site Not Available

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan 3173435, 20133
    Italy

    Active - Recruiting

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Irccs Istituto Clinico Humanitas

    Rozzano 3168837, 20089
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

    Verona, 37134
    Italy

    Site Not Available

  • Centro Ricerche Cliniche Di Verona

    Verona, 37134
    Italy

    Site Not Available

  • Centro Ricerche Cliniche Di Verona

    Verona 3164527, 37134
    Italy

    Active - Recruiting

  • National Cancer Center Hospital East

    Chiba, 277-8577
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Chiba 2113015, 277-0882
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of Jfcr

    Koto-ku, 135-8550
    Japan

    Site Not Available

  • The Cancer Institute Hospital of Jfcr

    Kōtoku 2128852, 135-8550
    Japan

    Site Not Available

  • The Cancer Institute Hospital of Jfcr

    Tokyo 1850147, 135-0063
    Japan

    Active - Recruiting

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital General Universitario Vall D Hebron

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Fundacian Jimnez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223
    Spain

    Active - Recruiting

  • Fundacion Jimenez Diaz

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud Madrid

    Madrid 3117735, 28223
    Spain

    Active - Recruiting

  • Mayo Clinic Hospital

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Mayo Clinic Hospital

    Phoenix 5308655, Arizona 5551752 85054
    United States

    Active - Recruiting

  • Stanford University

    Palo Alto, California 94305
    United States

    Site Not Available

  • UCLA Healthcare Hematology-Oncology

    Santa Monica, California 90404
    United States

    Site Not Available

  • Stanford University

    Palo Alto 5380748, California 5332921 94305
    United States

    Active - Recruiting

  • UCLA Healthcare Hematology-Oncology

    Santa Monica 5393212, California 5332921 90404
    United States

    Active - Recruiting

  • Sarah Cannon Research Institue At Healthone

    Denver, Colorado 80218
    United States

    Site Not Available

  • Sarah Cannon Research Institue At Healthone

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Florida Cancer Specialists

    Sarasota 4172131, Florida 4155751 34232
    United States

    Active - Recruiting

  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10022
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10021
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10022
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York 5128581, New York 5128638 10021
    United States

    Active - Recruiting

  • Jefferson University Hospitals

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Scri Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Scri Oncology Partners - Nashville

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Scri Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Md Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Md Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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