A Phase I/II, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors

Study Identifier:
TNG462-C101
CT.gov Identifier:
NCT05732831
EudraCT Identifier:
202250000000
EU Trial (CTIS) Number:
2022-502645-99-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

To evaluate TNG462 in non-small cell lung cancer, mesothelioma and cholangiocarcinoma. To Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors To evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of TNG462 in solid tumors with MTAP deletions. Phase 1: To determine the MTD and RP2D(s) of TNG462 when administered as single agent and in combination with pembrolizumab Phase 2: To assess antineoplastic activity of TNG462 in participants with MTAP-deleted advanced solid tumors when administered as a single agent and 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.
    I/II
    Sex
    Female & Male
    Age
    18 - 64 Years
    Study Drug
  • Drug: Experimental: Dose Escalation
    • Read More
  • Drug: 39 evaluable patients across 13 histologies at active doses (160-300 mg QD).
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Age: ≥18 years-of-age at the time of signature of the main study ICF
    • Performance status: ECOG Performance Score of 0 to 1
    • Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor
    • Prior standard therapy, as available
    • Documented bi-allelic (homozygous) deletion of MTAP in a tumor detected by next- generation sequencing or absence of MTAP protein in a tumor detected by IHC.
    • Adequate organ function/reserve per local labs
    • Adequate liver function per local labs
    • Adequate renal function per local labs
    • Negative serum pregnancy test result at screening
    • Written informed consent must be obtained according to local guidelines
    Exclusion criteria
    • Known allergies, hypersensitivity, or intolerance to TNG462 or its excipients
    • Uncontrolled intercurrent illness that will limit compliance with the study requirements
    • Active infection requiring systemic therapy
    • Currently participating in or has planned participation in a study of another investigational agent or device
    • Impairment of GI function or disease that may significantly alter the absorption of oral TNG462
    • Active prior or concurrent malignancy.
    • Central nervous system metastases associated with progressive neurological symptoms
    • Current active liver disease from any cause
    • Known to be HIV positive, unless all of the following criteria are met:
    • CD4+ count ≥300/L
    • Undetectable viral load
    • Receiving highly active antiretroviral therapy
    • Clinically relevant cardiovascular disease
    • A female patient who is pregnant or lactating
    • Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions
    • Patient has a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, may affect the safety of the patient or impair the assessment of study results

    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
    Solid Tumor
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Blanca Arderius Martin
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor