Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 or Karnofsky performance status
score ≥ 70.
3. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or
unresectable solid tumor or for GBM, have R/R disease.
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 TNG908 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 TNG908
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
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 1/24/2024. Questions regarding updates should be directed to the study team contact.