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Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors

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Brief Summary

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, TNG908, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 192 participants.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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 or Karnofsky performance status score ≥70.
  • Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor or for GBM, have R/R disease.
  • 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 TNG908 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 TNG908
  • 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/μL
    • 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

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Study Stats
Protocol No.
23-000436
Category
Other Cancer
Contact
Emese Filka
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05275478
For detailed technical eligibility, visit ClinicalTrials.gov.