Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IDE161
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 | 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 |
IDE-161 is an investigational small molecule being developed 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 currently in Phase 1 clinical development.
IDE-161 targets B7H3, a protein involved in tumor immune evasion. As a small molecule, it is designed to modulate this target in the treatment of advanced solid tumors. The drug is being studied in a Phase 1 clinical trial for its safety and efficacy.
IDE-161 is being developed by IDEAYA Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IDYA. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced or metastatic solid tumors.
IDE-161 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, and the drug has received Fast Track designation from the FDA.
IDE-161 is being studied in a single Phase 1 clinical trial with the identifier NCT05787587, titled 'A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors.' The trial is active but not recruiting, with an estimated enrollment of 216 participants in the United States.
Yes, IDE-161 and IDE161 refer to the same investigational drug. The compound is being developed by IDEAYA Biosciences for the treatment of advanced or metastatic solid tumors and is currently in Phase 1 clinical trials.