Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IDE-161 · 1 trial · 9 indications
* Incidence of Dose Limiting Toxicities * Incidence of treatment-emergent Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy * Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
* Incidence of treatment-emergent AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy * Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing
Tumor response: Overall Response Rate assessed using RECIST criteria v1.1
| Arm | Type | Description |
|---|---|---|
| Module 1 Part 1: Monotherapy Dose Escalation | EXPERIMENTAL | Participants will be assigned to a dose level. |
| Module 1 Part 2: Monotherapy Dose Expansion | EXPERIMENTAL | After a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level. |
| Module 2 Part 1: Combination Dose Escalation with pembrolizumab | EXPERIMENTAL | Participants will be assigned to a dose level. |
| Module 2 Part 2: Combination Dose Expansion with pembrolizumab | EXPERIMENTAL | After a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level. |
| Name | Type | Description |
|---|---|---|
| IDE-161 | DRUG | Oral Medication |
| Pembrolizumab | DRUG | Intravenous Infusion |
Inclusion Criteria: 1. Adult participants must be 18 years of age or older 2. Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors 3. For Module 1 only, Have documented evidence of BRCA1/2 and/or genetic alterations conferring homologous recombination deficiency...
| 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 |
IDE-161 is an investigational small molecule PARG inhibitor being developed by IDEAYA Biosciences for advanced or metastatic solid tumors. It is in Phase 1 clinical development and is designed to target tumors with specific biomarker selection. IDE-161 is not yet approved for any indication.
IDE-161 is being studied for the treatment of advanced or metastatic solid tumors, including breast, ovarian, prostate, endometrial, colorectal, head and neck cancers, extensive stage small cell lung cancer, and non-small cell lung cancer. It is investigational and has not been approved for any use.
IDE-161 targets B7H3. It is a small molecule designed to inhibit PARG, and its development is biomarker-selected, meaning it is evaluated in patients whose tumors express certain biomarkers. The B7H3 target is central to its mechanism of action in advanced solid tumors.
IDE-161 is being developed by IDEAYA Biosciences, Inc., a biotechnology company whose common stock trades on the Nasdaq under the ticker IDYA. IDEAYA is the sponsor of the clinical program evaluating IDE-161 in advanced solid tumors.
IDE-161 is in Phase 1 clinical development. The ongoing trial is active but not recruiting, and no Phase 2 or Phase 3 trials have been initiated. IDE-161 remains an investigational agent and is not FDA approved.
IDE-161 is being evaluated in a single Phase 1 trial, NCT05787587, titled A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors. The trial has an enrollment of 216 participants, is active but not recruiting, and is conducted in the United States.
Yes, IDE-161 and IDE161 refer to the same investigational drug. IDE161 is an alternative spelling of IDE-161, and both names are used interchangeably in reference to the PARG inhibitor being developed by IDEAYA Biosciences for advanced solid tumors.