Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06922591 | Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients | PHASE1 | RECRUITING | 183 | — | — | May 31, 2025 | Dec 1, 2027 | May 14, 2026 | 18 | United States |
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
| 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 |
| 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 |
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...