NCT05091346

A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors

An Open-Label, Multicenter, Phase 1b/2 Study of E7386 in Combination With Pembrolizumab in Previously Treated Subjects With Selected Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma
• Carcinoma, Hepatocellular
• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	E7386	E7386 tablet.
DRUG	Pembrolizumab	Pembrolizumab IV infusion.
DRUG	Lenvatinib	Lenvatinib capsule.

Timeline

• Start date: 2021-10-27
• Primary completion: 2024-10-15
• Completion: 2024-10-15
• First posted: 2021-10-25
• Last updated: 2025-10-24
• Results posted: 2025-10-24

Locations

32 sites across 4 countries: United States, Japan, Spain, United Kingdom

Regulatory

• FDA-regulated drug study