Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EIK1005 · 1 trial · 7 indications
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 | 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 |
EIK1005 is an investigational small molecule being studied in adults with advanced solid tumors. The Phase 1 trial enrolls patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) tumors, including gastric, colorectal, gastroesophageal junction, and endometrial cancers. It is not approved for any use.
EIK1005 targets WRN, the Werner syndrome helicase. WRN is a helicase enzyme that certain MSI-H and dMMR tumor cells depend on for survival, which is why the program is biomarker selected for mismatch repair deficient or microsatellite instability high cancers.
EIK1005 is being developed by Eikon Therapeutics, Inc., which trades under the ticker EIKN. The company is running the Phase 1 study as a monotherapy and in combination with pembrolizumab in advanced solid tumors.
EIK1005 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The single active study is currently recruiting participants.
EIK1005 is being evaluated in the recruiting Phase 1 trial NCT07262619, titled EIK1005-002. The study tests EIK1005 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors, including MSI-H tumors, and plans to enroll about 160 patients across the United States, Europe, Asia, and Australia.