RecruitingPhase 1NCT07204340

TLN-372 in Advanced KRAS Mutant Solid Tumors

An Open-Label, Multicenter, Phase 1 Trial 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


Sponsor

Treeline Biosciences, Inc.

Enrollment

240 participants

Start Date

Sep 29, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • Patients must have measurable disease at study entry.
  • Patients must have locally advanced or metastatic KRAS mutant solid tumors.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function.

Exclusion Criteria7

  • Patients must not have active brain metastases.
  • Patients must not have current or past history of central nervous system (CNS) involvement.
  • Patients must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
  • Patients must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places patients at unacceptable risk of participating in this study.
  • Patients must not have clinically significant cardiovascular disease.
  • Pregnant or lactating.
  • Conditions that could affect drug absorption.

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Interventions

DRUGTLN-372

Specified dose on specified days

DRUGTLN-372 in combination with cetuximab

Specified dose on specified days

DRUGTLN-372 in combination with pembrolizumab

Specified dose on specified days


Locations(10)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

START Midwest

Grand Rapids, Michigan, United States

Washington University Medical Campus

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Linear Clinical Research

Perth, Western Australia, Australia

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT07204340