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
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