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Clinical Trials in Spain / NCT07204340
Recruiting Phase 1

TLN-372 in Advanced KRAS Mutant Solid Tumors

NCT07204340 · tracked via the Priya Life Science Spain tracker
Sponsor
Treeline Biosciences, Inc
Phase
Phase 1
Started
2025-09-29
Last updated
2026-07-28

Condition(s) studied

KRAS Mutant Solid Tumors

Investigational drug(s) / intervention(s)

TLN-372TLN-372 in combination with cetuximab →TLN-372 in combination with pembrolizumab →

TLN-372: Specified dose on specified days

TLN-372 in combination with cetuximab: Specified dose on specified days

TLN-372 in combination with pembrolizumab: Specified dose on specified days

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372 — Up to 2 years
  • Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation. — Up to 2 years
  • Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1 — Up to 2 years

Trial sites (11)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07204340 on ClinicalTrials.gov ↗ ← All trials in Spain