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TNG456 · 1 trial · 7 indications
To determine the MTD, recommended dose(s) (RD), and dosing schedule of TNG456 monotherapy and in combination with abemaciclib
To assess the antitumor activity of TNG456 in patients with advanced or metastatic solid tumors with MTAP loss by RECIST or modified RANO criteria
To assess the antitumor activity of TNG456 in combination with abemaciclib in patients with advanced or metastatic tumors with MTAP loss by RECIST or modified RANO criteria
| Arm | Type | Description |
|---|---|---|
| Single Agent and Combination Dose Escalation | EXPERIMENTAL | Solid tumor participants with confirmed MTAP loss will receive escalating doses of TNG456 single agent and in combination with abemaciclib to estimate the MTD |
| NSCLC Single Agent Dose Expansion | EXPERIMENTAL | NSCLC (squamous and non squamous) participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) |
| GBM Single Agent Dose Expansion | EXPERIMENTAL | GBM participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) |
| Tumor Agnostic Single Agent Dose Expansion | EXPERIMENTAL | Patients with specific solid tumor types that have a confirmed MTAP loss will receive TNG456 at the identified RP2D(s) |
| NSCLC Combination Expansion | EXPERIMENTAL | NSCLC (squamous and non-squamous) participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib |
| GBM Combination Expansion | EXPERIMENTAL | GBM participants with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib |
| Tumor Agnostic Combination Expansion | EXPERIMENTAL | Participants with specific tumor types with confirmed MTAP loss will receive TNG456 at the identified RP2D(s) with abemaciclib |
| Name | Type | Description |
|---|---|---|
| TNG456 | DRUG | A selective PRMT5 inhibitor |
| abemaciclib | DRUG | A kinase inhibitor |
Inclusion Criteria: * Has a tumor with a confirmed MTAP loss * Is ≥18 years of age at the time of signature of the main study ICF * Has had progression or an inadequate response to or is intolerant of the approved standard of care therapy, no standard of care therapy exists, or the investigator has...
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TNG456 is an investigational small molecule being studied in adults with solid tumors, including non small cell lung cancer. It is being evaluated in patients whose tumors show MTAP loss, a biomarker-selected population. TNG456 has not been approved for any indication and remains in clinical development.
TNG456 targets PRMT5, a protein arginine methyltransferase. The compound is designed to inhibit PRMT5 in tumor cells that have lost the MTAP gene, a biomarker-selected approach. This mechanism is being tested in a Phase 1 study in solid tumors including non small cell lung cancer.
TNG456 is being developed by Tango Therapeutics, Inc., which trades on the Nasdaq under the ticker TNGX. The company is running a Phase 1 clinical trial of the drug in patients with solid tumors characterized by MTAP loss.
TNG456 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The ongoing Phase 1 trial is evaluating safety and tolerability in patients with solid tumors with MTAP loss.
TNG456 is being studied in one active clinical trial, NCT06810544, titled Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss. The Phase 1 study is recruiting in the United States and has an enrollment target of 191 participants.
Yes. Non small cell lung cancer is among the conditions included in the Phase 1 trial of TNG456, NCT06810544. The study enrolls adults with solid tumors showing MTAP loss and also includes glioma, glioblastoma multiforme, brain tumor, and other solid tumor types.