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

Prior treatment

• Currently participating in or has planned participation in a study of another investigational agent or device
• Active prior or concurrent malignancy.

Other illness

• Known allergies, hypersensitivity, or intolerance to TNG462, or its excipients or to pembrolizumab in the combination treatment arms
• Uncontrolled intercurrent illness that will limit compliance with the study requirements
• Active infection requiring systemic therapy
• Impairment of GI function or disease that may significantly alter the absorption of oral TNG462
• Current active liver disease from any cause
• Clinically relevant cardiovascular disease

Lab values

• 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
• 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

Other

• Central nervous system metastases associated with progressive neurological symptoms
• A female patient who is pregnant or lactating

• 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