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Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors

Published: February 24, 2023

Primary Outcome Measures

  1. Phase 1 Maximum Tolerated Dose [ Time Frame: 28 days ]
    To determine the maximum tolerated dose (MTD) of TNG462
  2. Phase 1 Dosing Schedule [ Time Frame: 28 days ]
    To determine the dosing schedule of TNG462
  3. Phase 2 Anti-neoplastic Activity [ Time Frame: 16 weeks ]
    To assess anti-neoplastic activity of TNG462 in patients with MTAP-deleted advanced solid tumors by RECIST v1.1

Secondary Outcome Measures

  1. Phase 1 Anti-neoplastic Activity [ Time Frame: 16 weeks ]
    To assess preliminary evidence of anti-neoplastic activity of TNG462 in patients with MTAP-deleted advanced solid tumors by RECIST v1.1
  2. Phase 1 and 2 Adverse Event Profile [ Time Frame: 28 days ]
    To describe the safety and tolerability profile of TNG462 by frequency and severity of AEs
  3. Phase 1 and 2 Concentration versus Time Curve [ Time Frame: 16 days ]
    Measure the area under the plasma concentration versus time curve (AUC)
  4. Phase 1 and 2 Time to Achieve Maximal Plasma Concentration [ Time Frame: 16 days ]
    Measure the time to achieve maximal plasma concentration (Tmax)
  5. Phase 1 and 2 Maximum Observed Plasma Concentration [ Time Frame: 16 days ]
    Measure the maximum observed plasma concentration (Cmax)
  6. Phase 1 and 2 Terminal Elimination Half-life [ Time Frame: 16 days ]
    Determine the terminal elimination half-life (t1/2)
  7. Phase 1 and 2 Total Plasma Clearance [ Time Frame: 16 days ]
    Determine the apparent total plasma clearance when dosed orally (CL/F)
  8. Phase 1 and 2 Volume of Distribution [ Time Frame: 16 days ]
    Determine the apparent volume of distribution when dosed orally (Vz/F)
  9. Phase 1 and 2 SDMA Levels [ Time Frame: 28 days ]
    SDMA levels in tumor tissue will be assessed pre-treatment and post treatment with TNG462

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
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