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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07262619 | EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors | PHASE1 | RECRUITING | 160 | — | — | Jan 20, 2026 | Mar 1, 2029 | Apr 8, 2026 | 10 | United States, Australia +1 |
A DLT is a protocol-defined adverse event occurring during the DLT observation period.
Number of participants reporting adverse events or serious adverse events.
| Arm | Type | Description |
|---|---|---|
| Part 1A (Dose escalation, Monotherapy) | EXPERIMENTAL | EIK1005 will be given as monotherapy in participants without alternative treatment options. |
| Part 1B (Dose escalation, Combination with pembrolizumab) | EXPERIMENTAL | EIK1005 will be given in combination with pembrolizumab to participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) solid tumors. |
| Part 2 (Dose optimization, Monotherapy) | EXPERIMENTAL | Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) advanced solid tumors will be randomized to receive EIK1005 monotherapy at one of the two identified doses selected from Part 1A. |
| Name | Type | Description |
|---|---|---|
| EIK1005 | DRUG | EIK1005 is a selective inhibitor of the Werner helicase. |
| pembrolizumab (KEYTRUDA® ) | DRUG | Pembrolizumab is a PD-1 inhibitor. |
Key Inclusion Criteria: 1. is ≥ 18 years of age at the time of signing the informed consent. 2. has a life expectancy of at least 3 months. 3. has histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor. Part 1A: recommend that participants have archival tis...
| 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 |