TLN-372 in Advanced KRAS Mutant Solid Tumors

Last updated: April 20, 2026
Sponsor: Treeline Biosciences, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

TLN-372

TLN-372 in combination with cetuximab

TLN-372 in combination with pembrolizumab

Clinical Study ID

NCT07204340
TLN-372-2501
  • Ages > 18
  • All Genders

Study Summary

The primary purpose of this study is to evaluate the safety, pharmacokinetics, and anti-tumor activity of TLN-372 as a single agent and in combination with other anti-tumor agents, in patients with advanced KRAS mutant solid tumors

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must have measurable disease at study entry.

  2. Patients must have locally advanced or metastatic KRAS mutant solid tumors.

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

  4. Adequate organ function.

Exclusion

Exclusion Criteria:

  1. Patients must not have active brain metastases.

  2. Patients must not have current or past history of central nervous system (CNS)involvement.

  3. Patients must not have major surgery or severe trauma within 4 weeks prior to thestart of the study.

  4. Patients must not have any condition, including significant acute or chronic medicalillness, active or uncontrolled infection, or the presence of laboratoryabnormalities, that places patients at unacceptable risk of participating in thisstudy.

  5. Patients must not have clinically significant cardiovascular disease.

  6. Pregnant or lactating.

  7. Conditions that could affect drug absorption.

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: TLN-372
Phase: 1
Study Start date:
September 29, 2025
Estimated Completion Date:
April 01, 2032

Connect with a study center

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne 2158177, Victoria 2145234
    Australia

    Site Not Available

  • Linear Clinical Research

    Perth, Western Australia 6009
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Perth 2063523, Western Australia 2058645 6009
    Australia

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 1X6
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto 6167865, Ontario 6093943 M5G 1X6
    Canada

    Site Not Available

  • Hospital Universitary Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

    Madrid, 28050
    Spain

    Active - Recruiting

  • START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

    Madrid 3117735, 28050
    Spain

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35294
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215-5450
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215-5450
    United States

    Site Not Available

  • START Midwest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • START Midwest

    Grand Rapids 4994358, Michigan 5001836 49546
    United States

    Site Not Available

  • Washington University Medical Campus

    St Louis, Missouri 63108
    United States

    Active - Recruiting

  • Washington University Medical Campus

    St Louis 4407066, Missouri 4398678 63108
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021-3402
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10021-3402
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

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