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

NCT#: & Link

NCT05275478

NCT QR Code

Available as of:

July 3, 2024

Contract:

Optimal

Indication Category:

Solid Tumors

Study Sponsor:

Tango Therapeutics

Protocol #:

TNG908- C101

Title:

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

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG908 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors (TNG908-C101+J13

Highlight Details:

• ECOG 0-1
• confirmed histologic or cytologic diagnosis of a locally advanced or metastatic solid tumor
• Measurable disease based on RECIST, v1.1
• Documented bi-allelic (homozygous) deletion of MTAP in a tumor detected by a validated NGS test, or absence of MTAP protein in a tumor detected by a validated IHC test.
• Adequate organ and hematological functions
• Arm 2: Patients with locally advanced or metastatic mesothelioma, or after following
• local treatment guidelines (ie, ESMO guidelines) for the standard of care if more strict
• Mesothelioma, any location
• Progressive disease after prior treatment
• At least 1 of the following criteria for standard-of-care therapy(ies):
• a. Progression or an inadequate response to an approved standard-of-care therapy; there is no limit to the number of prior lines of therapy
• b. No approved standard-of-care therapy
• c. Patient is intolerant to the available standard-of-care therapy(ies)
• d. Investigator has determined that treatment with the standard-of-care therapy is not appropriate

Biomarkers:

MTAP-deletion

Indication:

Mesothelioma With MTAP deletion
ARM 2

Phase:

2

Treatment Line:

2nd+ line

Study Drug/Test Compound:

TNG908 is a potent and selective oral small- molecule inhibitor of PRMT5.

TNG908 binds cooperatively with MTA to inhibit PRMT5 function. Elevated levels of MTA are found in tumor cells that have lost the MTAP gene, which metabolizes MTA, conferring marked specificity of TNG908 for tumor cells that have lost MTAP but not normal cells

Notes

Phase 2 IP:TNG908 starting dose of 600mg BID PO

Recruitment Status:

Just In Time

Participating Institution:

Salinas Valley Health

Salinas Valley Health Clinical Research Program:

Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, [email protected]