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ACTIVE NOT RECRUITING
NCT04078295
PHASE1/PHASE2

A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor

Sponsor: Eisai Co., Ltd.

View on ClinicalTrials.gov

Summary

The primary purpose of the study is to evaluate safety and tolerability of E7389 liposomal formulation (E7389-LF) in combination with nivolumab and to determine the recommended Phase 2 dose (RP2D) in Phase 1b part and to evaluate objective response rate (ORR) of E7389-LF and nivolumab using RP2D in each tumor type in Phase 2 part.

Official title: An Open-Label Phase 1b/2 Study of E7389 Liposomal Formulation Plus Nivolumab in Subjects With Solid Tumor

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2019-09-05

Completion Date

2027-03-31

Last Updated

2026-02-10

Healthy Volunteers

No

Conditions

Interventions

DRUG

E7389-LF

E7389-LF Intravenous infusion.

DRUG

Nivolumab

Nivolumab Intravenous infusion.

Locations (19)

Eisai Trial Site #13

Nagoya, Aichi-ken, Japan

Eisai Trial Site #18

Kashiwa, Chiba, Japan

Eisai Trial Site #2

Kashiwa, Chiba, Japan

Eisai Trial Site #14

Matsuya, Ehime, Japan

Eisai Trial Site #4

Kurume, Fukuoka, Japan

Eisai Trial Site #11

Akashi, Hyōgo, Japan

Eisai Trial Site #15

Yokohama, Kanaga, Japan

Eisai Trial Site #3

Sendai, Miyagi, Japan

Eisai Trial Site #6

Chuo Ku, Osaka, Japan

Eisai Trial Site #8

Chuo Ku, Osaka, Japan

Eisai Trial Site #5

Osakasa, Osaka, Japan

Eisai Trial Site #7

Sakai C, Osaka, Japan

Eisai Trial Site #17

Suita, Osaka, Japan

Eisai Trial Site #19

Kitaadachi-gun, Saitama, Japan

Eisai Trail Site #16

Sunto-g, Shizuo, Japan

Eisai Trial Site #1

Chuo Ku, Tokyo, Japan

Eisai Trial Site #10

Koto-Ku, Tokyo, Japan

Eisai Trial Site #9

Wakayama, Wakaya, Japan

Eisai Trial Site #12

Kōtoku, Japan