Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TNG462 · 2 trials · 9 indications
To determine the MTD and RD(s) of TNG462 in combination with RMC-6236 or RMC-9805
To assess preliminary evidence of antineoplastic activity of TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel using RECIST 1.1
To determine the maximum tolerated dose (MTD) of TNG462 when administered as a single agent and in combination with pembrolizumab
To determine the dosing schedule of TNG462
To assess anti-neoplastic activity of TNG462 administered single agent and in combination with pembrolizumab in patients with MTAP-deleted advanced solid tumors by RECIST v1.1, iRECIST or mRECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Dose Escalation 1A | EXPERIMENTAL | Escalating oral doses of TNG462 in combination with oral RMC-6236 |
| Dose escalation 1B | EXPERIMENTAL | Escalating oral doses of TNG462 in combination with oral RMC-9805 |
| Dose Expansion 2A | EXPERIMENTAL | Expansion arm at the RDE(s) of oral TNG462 in combination with oral RMC-6236 |
| Dose Expansion 2B | EXPERIMENTAL | Expansion arm at the RDE(s) of oral TNG462 in combination with oralRMC-9805 |
| Experimental: Dose Escalation 1C | EXPERIMENTAL | Escalating doses of TNG462 in combination with mFOLFIRINOX |
| Experimental: Dose Escalation 1D | EXPERIMENTAL | Escalating doses of TNG462 in combination with gemcitabine/nab-paclitaxel |
| Experimental: Dose Expansion 2C | EXPERIMENTAL | Expansion arm at the RDE(s) of TNG462 in combination with mFOLFIRINOX |
| Experimental: Dose Expansion 2D | EXPERIMENTAL | Expansion arm at the RDE(s) of TNG462 in combination with gemcitabine/nab-paclitaxel |
| Dose Escalation | EXPERIMENTAL | Participants with MTAP-deleted solid tumors (excluding primary CNS) will receive escalating doses of TNG462 single agent and in combination with pembrolizumab to estimate the MTD |
| Dose Expansion in NSCLC | EXPERIMENTAL | Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG462 at the identified RP2D(s) |
| Dose Expansion in Mesothelioma | EXPERIMENTAL | Participants with MTAP-deleted mesothelioma will receive TNG462 at the identified RP2D(s) |
| Dose Expansion in Pancreatic Ductal Adenocarcinoma | EXPERIMENTAL | Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG462 at the identified RP2D(s) |
| Dose Expansion in Sarcoma | EXPERIMENTAL | Participants with MTAP-deleted sarcoma (soft tissue or bone) will receive TNG462 at the identified RP2D(s) |
| Dose Expansion in Solid Tumors | EXPERIMENTAL | Participants with other MTAP-deleted solid tumors will receive TNG462 at the identified RP2D(s) |
| Dose Expansion in NSCLC in Combination with Pembrolizumab | EXPERIMENTAL | Participants NSCLC (squamous and non squamous) MTAP-deleted solid tumors will receive TNG462 at the identified RP2D(s) |
| Name | Type | Description |
|---|---|---|
| TNG462 | DRUG | MTA cooperative PRMT5 inhibitor |
| RMC-9805 | DRUG | RAS(ON) G12D selective covalent inhibitor |
| RMC-6236 | DRUG | RAS(ON) multi-selective inhibitor |
| mFOLFIRINOX | DRUG | Chemotherapy |
| gemcitabine/nab-paclitaxel | DRUG | Chemotherapy |
| Pembrolizumab | DRUG | An anti PD-1 antibody, will be administered intravenously |
Inclusion Criteria: 1. Is ≥18 years of age at the time of signature of the main study ICF. 2. Has an ECOG PS of 0 or 1. 3. Has a tumor with loss of MTAP protein or bi-allelic deletion of the MTAP gene 4. Arms A and B only: Has a tumor with a RAS mutation 5. Pathologically documented metastatic PDAC...
TNG462 is an investigational small molecule being developed for oncology indications, including locally advanced solid tumors and pancreatic ductal adenocarcinoma (PDAC). It is being studied in patients with MTAP-deleted solid tumors and in combination regimens for PDAC and non-small cell lung cancer (NSCLC) with RAS mutations and MTAP deletions.
TNG462 targets PRMT5, a protein methyltransferase involved in cellular processes relevant to cancer. By inhibiting PRMT5, TNG462 is being evaluated as a potential treatment for tumors with MTAP deletions, which are common in certain cancers such as pancreatic ductal adenocarcinoma and non-small cell lung cancer.
TNG462 is being developed by Tango Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol TNGX. The company is conducting clinical trials to evaluate the safety, tolerability, and efficacy of TNG462 in patients with specific solid tumor types.
TNG462 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trials are recruiting patients to assess the safety, tolerability, and preliminary efficacy of TNG462 as a monotherapy and in combination with other agents.
TNG462 is being studied in two Phase 1 clinical trials. NCT05732831 evaluates TNG462 monotherapy in patients with MTAP-deleted solid tumors across the United States, France, and Spain. NCT06922591 evaluates TNG462 in combination for PDAC and NSCLC patients with RAS mutations and MTAP deletions in the United States.
TNG462 is a distinct investigational compound developed by Tango Therapeutics. It is not known to be the same as any other marketed drug. Its unique mechanism of targeting PRMT5 in MTAP-deleted tumors differentiates it from other cancer therapies currently in development.