Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IDE397 · 1 trial · 1 indication
Incidence of DLTs of IDE397 will be determined
Incidence of DLTs of IDE397 in a combination setting will be determined
MTD and RP2D of IDE397 will be determined
MTD and RP2D of IDE397 in a combination setting will be determined
Objective Response Rate (ORR) and Duration of Response (DoR)
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation Monotherapy (Solid Tumors) | EXPERIMENTAL | - |
| Part 2: Monotherapy Dose Expansion (NSCLC and Urothelial) | EXPERIMENTAL | - |
| Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (NSCLC and Urothelial) | EXPERIMENTAL | - |
| Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (NSCLC and Urothelial) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| IDE397 | DRUG | IDE397 dosed orally |
| Sacituzumab govitecan | DRUG | Intravenous infusion |
Inclusion Criteria: * Participant must be at least 18 years of age * Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy * Have evidence of homozygous loss of MTAP or MTAP deletion * Willing to unde...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
IDE397 is an investigational small molecule being studied for the treatment of solid tumors that harbor a MTAP deletion. It is currently in Phase 1 clinical development for this patient population.
IDE397 targets MAT2A, an enzyme involved in cancer cell metabolism. By inhibiting MAT2A, the drug is designed to exploit vulnerabilities in tumors with MTAP deletions, potentially leading to cancer cell death.
IDE397 is being developed by IDEAYA Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IDYA.
IDE397 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities.
IDE397 is being evaluated in a Phase 1 clinical trial with the identifier NCT04794699. This study is investigating the drug in participants with solid tumors harboring MTAP deletion and is active but not recruiting.
IDE397 is the primary name for this investigational drug. No alternative names have been reported for this asset.