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

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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 170 participants.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tango Therapeutics, Inc.

Criteria

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.

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. Patient must be able to swallow tablets

11. 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. Diagnosis of malignant glioma

5. Currently participating in or has planned participation in a study of another investigational agent or device

6. Impairment of GI function or disease that may significantly alter the absorption of oral TNG908

7. Active prior or concurrent malignancy.

8. Central nervous system metastases associated with progressive neurological symptoms

9. Current active liver disease from any cause

10. 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

11. Clinically relevant cardiovascular disease

12. A female patient who is pregnant or lactating

13. Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions

14. 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