| NCT#: & Link | NCT05732831 |
| NCT QR Code |  |
| Available as of: | October 1, 2024 |
| Contract: | Optimal |
| Indication Category: | Solid Tumors |
| Study Sponsor: | Tango Therapeutics |
| Protocol #: | TNG462-C101 |
| Title: | A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors |
| Highlight Details: | • ECOG 0-1 • Participants with locally advanced or metastatic NSCLC (squamous or non-squamous) who meet the following criteria: • a. Progressive disease after prior treatment or after following local treatment guidelines (eg, ESMO guidelines) for the standard of care (SOC) if more strict. • b. Tested for known treatable driver mutations/alterations (eg, EGFR, ALK, and ROS1) and received at least 1 SOC targeted therapy(ies) for the known alteration, if present or after failing local treatment guidelines (eg, ESMO or study guidelines) for the SOC if more strict. • Measurable disease based on RECIST v1.1 • Documented 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 • At least 1 of the following criteria for standard-of-care therapy(ies): • a. Progression or an inadequate response to an approved SOC therapy; there is no limit to the number of prior lines of therapy • b. No approved SOC therapy • c. Patient intolerant to the available SOC therapy(ies) • d. Investigator has determined that treatment with the SOC therapy is not appropriate |
| Biomarkers: | MTAP-deletion |
| Indication: | NSCLC with MTAP deletion |
| Phase: | 2 |
| Treatment Line: | 2nd+ line |
| Study Drug/Test Compound: | TNG462 is a potent and selective oral small molecule inhibitor of PRMT5. TNG462 binds PRMT5 cooperatively with MTA to inhibit function. As an MTA cooperative inhibitor with selectivity for patients whose tumors are MTAP deleted, TNG462 addresses the 2 challenges of tumor selectivity and patient selection |
| Notes | 462 more selective/potent at a lower dose then 908 462 not brain penetrant, less risk for cognitive disturbance (but not useful for brain lesions) Phase 2 IP: TNG462 QD starting dose of 200mg PO |
| Recruitment Status: | Just In Time – ON HOLD |
| Participating Institution: | Salinas Valley Health |
| Salinas Valley Health Clinical Research Program: | Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, [email protected] |
(Tumor Board) & Other Clinical Trials at Salinas Valley Health
