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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
IDE397 is an investigational small molecule developed by IDEAYA Biosciences for the treatment of solid tumors. It is being studied in patients whose tumors harbor an MTAP deletion, a biomarker-selected population. IDE397 is currently in Phase 1 clinical development and has not been approved by the FDA.
IDE397 targets MAT2A, an enzyme. By acting on this enzyme, IDE397 is designed to affect tumors that carry an MTAP deletion, which is the biomarker used to select patients for its clinical study. MAT2A is the molecular target of the small molecule.
IDE397 is being developed by IDEAYA Biosciences, Inc., which trades under the ticker IDYA. The company is the sponsor of the clinical program evaluating IDE397 in solid tumors harboring MTAP deletion.
IDE397 is in Phase 1 clinical development. It is an investigational drug and is not FDA approved. The Phase 1 study is currently active but not recruiting participants, and no completed trials of IDE397 have been reported.
IDE397 is being evaluated in one clinical trial, NCT04794699, titled Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion. The Phase 1 trial has enrolled 169 participants, is active but not recruiting, and is conducted in the United States, Australia, France, Germany, South Korea, Spain, and Taiwan.
IDE397 is being studied for the treatment of solid tumors that harbor an MTAP deletion. The Phase 1 trial NCT04794699 enrolls adults 18 years and older with this biomarker-selected tumor type. Use of IDE397 remains investigational, as the drug is still in clinical development.