drugset / Trial / NCT05091346
A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors
RandomizedSequentialOpen-labelTreatment
Summary
The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with pembrolizumab. The Phase 2 part of this study is conducted to assess the objective response rate (ORR) of E7386 in combination with pembrolizumab (melanoma, colorectal cancer \[CRC\], hepatocellular carcinoma \[HCC\]) or of E7386 in combination with pembrolizumab plus lenvatinib (HCC) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Timeline
- Start
- 2021-10-27
- Primary completion
- 2024-10-15
- Completion
- 2024-10-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | E7386 | Small molecule | — | Oral |
| Subject | Lenvatinib | Small molecule | 8 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |