Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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 or to
pembrolizumab in the combination treatment arms
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
