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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05787587 | A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 216 | — | — | Apr 18, 2023 | May 1, 2027 | Jun 2, 2026 | 23 | United States |
* 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, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |