TLN-372 for advanced KRAS‑mutant solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study tests TLN-372 as a single agent and in combination with cetuximab or pembrolizumab in adults with locally advanced or metastatic KRAS‑mutant solid tumors. The primary goals are to define safety, pharmacokinetics, and preliminary anti‑tumor activity in patients with measurable disease, ECOG 0–1, and adequate organ function. Key exclusions include active brain metastases or CNS involvement, recent major surgery, significant cardiovascular disease, pregnancy or lactation, and conditions that could affect drug absorption. The trial is sponsored by Treeline Biosciences and is being conducted at U.S. cancer centers including Dana‑Farber, University of Alabama at Birmingham, and START Midwest.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• Washington University Medical Campus
  St Louis, Missouri, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Sarah Cannon Research Institute
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Treeline Clinical Operations
• Email: clinicaloperations@treeline.bio
• Phone: 857-228-0050

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.