Back to Trials
NCT07204340PHASE1Recruiting

TLN-372 in Advanced KRAS Mutant Solid Tumors

Treeline Biosciences, Inc.

Start Date

9/29/2025

Completion Date

4/1/2032

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

Age Range: 18 years to No maximum

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 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 the start of the study. 4. 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. 5. Patients must not have clinically significant cardiovascular disease. 6. Pregnant or lactating. 7. Conditions that could affect drug absorption.

Interventions

DRUG

TLN-372

DRUG

TLN-372 in combination with cetuximab

DRUG

TLN-372 in combination with pembrolizumab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

KRAS Mutant Solid Tumors

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215-5450

United States

START Midwest

Grand Rapids, Michigan 49546

United States

Washington University Medical Campus

St Louis, Missouri 63108

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10021-3402

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

Peter MacCallum Cancer Centre

Melbourne, Victoria

Australia

Linear Clinical Research

Perth, Western Australia 6009

Australia

Princess Margaret Cancer Centre

Toronto, Ontario M5G 1X6

Canada

Hospital Universitary Vall d'Hebron

Barcelona, 08035

Spain

START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

Madrid, 28050

Spain