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:
202552000000
EU Trial (CTIS) Number:
N/A
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

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.
  • Biomarkers
    • 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.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Combination Treatment
    • Read More
  • Drug: Drug: TLN-372 in combination with cetuximab
  • Drug: Specified dose on specified days
  • Drug: Drug: TLN-372 in combination with pembrolizumab
  • Drug: EXPERIMENTAL: Single Agent
  • Drug: Drug: TLN-372
    • 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 Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruiting
    Condition(s) Treated at Site
    Biomarkers
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruiting
    Condition(s) Treated at Site
    Biomarkers