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TLN-372 in Advanced KRAS Mutant Solid Tumors

RECRUITINGPhase 1Sponsored by Treeline Biosciences, Inc.
Actively Recruiting
PhasePhase 1
SponsorTreeline Biosciences, Inc.
Started2025-09-29
Est. completion2031-12-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations6 sites

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

CancerKRAS Mutant Solid Tumors

Locations6 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35294
Rebecca Arendrarend@uabmc.edu
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215-5450
START Midwest
Grand Rapids, Michigan, 49546
Principal Investigator616-954-5554Angela.galindo@startresearch.com
Washington University Medical Campus
St Louis, Missouri, 63108
Gina Vellequette314-253-0616g.vellequette@wustl.edu
Memorial Sloan Kettering Cancer Center
New York, New York, 10021-3402
Jamie Walters917-843-7966

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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