TLN-372 in Advanced KRAS Mutant Solid Tumors

Recruiting now · Phase 1

Conditions studied: KRAS Mutant Solid Tumors

In brief

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

Key facts

Study ID

NCT07204340

Run by

Treeline Biosciences, Inc.

People needed

270

Starts

2025-09-29

Expected to finish

2032-04-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• Washington University Medical Campus — St Louis, Missouri, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• Linear Clinical Research — Perth, Western Australia, Australia (enrolling)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• Hospital Universitary Vall d'Hebron — Barcelona, Spain (enrolling)
• START Madrid_Hospital Universitario HM Sanchinarro_CIOCC — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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