An Open-Label, Multicenter, Phase 1 Trial 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

Study Identifier:
TLN-372-2501
CT.gov Identifier:
NCT07204340
EudraCT Identifier:
202552308622
EU Trial (CTIS) Number:
2025-523086-22-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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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

Part 1: To evaluate the safety and tolerability of TLN-372 in patients with locally advanced or metastatic KRAS mutant solid tumors and to estimate the maximum tolerated dose of TLN-372 as a single agent. Part 2: To evaluate the anti-tumor activity of TLN-372 as a single agent in patients with locally advanced or metastatic KRAS mutant solid tumors, to evaluate the anti-tumor activity of TLN-372 in combination with cetuximab and to evaluate the safety of TLN-372 in combination with pembrolizumab.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Nehal Lakhani
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Emiliano Calvo
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Neel Belani
Status
Recruitment on Hold
Condition(s) Treated at Site
Solid Tumor
Location
START Los Angeles
Los Angeles, CA, United States, 90025
Investigator
Status
Recruitment on Hold
Condition(s) Treated at Site
Solid Tumor
Location
START New York (Long Island)
Lake Success, NY, United States, 11042
Investigator
Geraldine O'Sullivan Coyne
Status
Recruitment on Hold
Condition(s) Treated at Site
Solid Tumor
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
Status
Recruitment on Hold
Condition(s) Treated at Site
Solid Tumor