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

NCT04078295 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

  • Solid Neoplasms

Interventions

DRUG

E7389-LF

E7389-LF Intravenous infusion.

DRUG

Nivolumab

Nivolumab Intravenous infusion.

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    collaborator INDUSTRY

  • Eisai Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-05
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04078295 on ClinicalTrials.gov