Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 159 participants.
Conditions:
🦠 Locally Advanced Solid Tumor
🗓️ Study Start (Actual) 26 May 2023
🗓️ Primary Completion (Estimated) May 2026
✅ Study Completion (Estimated) September 2026
👥 Enrollment (Estimated) 159
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Palo Alto, California, United States
📍 Miami, Florida, United States
📍 Boston, Massachusetts, United States
📍 Detroit, Michigan, United States
📍 New York, New York, United States
📍 Nashville, Tennessee, United States
📍 Houston, Texas, United States
📍 Salt Lake City, Utah, United States
📍 Lyon, France
📍 Villejuif, France
📍 Barcelona, Catalonia, Spain
📍 Madrid, Spain
📍 Madrid, Spain

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Age: ≥18 years-of-age at the time of signature of the main study ICF
    • 2. Performance status: ECOG Performance Score of 0 to 1
    • 3. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor
    • 4. Prior standard therapy, as available
    • 5. 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.
    • 6. Adequate organ function/reserve per local labs
    • 7. Adequate liver function per local labs
    • 8. Adequate renal function per local labs
    • 9. Negative serum pregnancy test result at screening
    • 10. Written informed consent must be obtained according to local guidelines

    Exclusion Criteria:

    • 1. Known allergies, hypersensitivity, or intolerance to TNG462 or its excipients
    • 2. Uncontrolled intercurrent illness that will limit compliance with the study requirements
    • 3. Active infection requiring systemic therapy
    • 4. Currently participating in or has planned participation in a study of another investigational agent or device
    • 5. Impairment of GI function or disease that may significantly alter the absorption of oral TNG462
    • 6. Active prior or concurrent malignancy.
    • 7. Central nervous system metastases associated with progressive neurological symptoms
    • 8. Current active liver disease from any cause
    • 9. Known to be HIV positive, unless all of the following criteria are met:
    • 1. CD4+ count ≥300/μL
    • 2. Undetectable viral load
    • 3. Receiving highly active antiretroviral therapy
    • 10. Clinically relevant cardiovascular disease
    • 11. A female patient who is pregnant or lactating
    • 12. Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions
    • 13. 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 January 2023
  • First Submitted that Met QC Criteria 7 February 2023
  • First Posted 17 February 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 May 2024
  • Last Update Posted 30 May 2024
  • Last Verified May 2024