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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 developed for non-small cell lung cancer and other solid tumors with MTAP loss. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied alone and in combination with abemaciclib.
TNG456 is being developed by Tango Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker TNGX. The company is conducting a Phase 1 clinical trial of TNG456 in patients with solid tumors that have MTAP loss.
TNG456 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Fast Track designation from the FDA, which is intended to expedite the development and review of drugs that treat serious conditions and fill unmet medical needs.
TNG456 is being studied in a Phase 1 clinical trial with the identifier NCT06810544. The trial is recruiting patients and is designed to evaluate the safety and tolerability of TNG456 alone and in combination with abemaciclib in patients with solid tumors with MTAP loss, including non-small cell lung cancer.
TNG456 targets tumors with MTAP loss, a genetic alteration found in certain cancers. The drug is designed to exploit this vulnerability, though the specific molecular target is not disclosed in the available information. It is being tested as a monotherapy and in combination with abemaciclib.
No, TNG456 is not the same as abemaciclib. TNG456 is an investigational drug being developed by Tango Therapeutics, while abemaciclib is an approved CDK4/6 inhibitor. In the ongoing Phase 1 trial, TNG456 is being tested both alone and in combination with abemaciclib.