Overview

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

Status:
Recruiting

Trial end date:
2022-12-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Eisai Co., Ltd.

Collaborator:

Ono Pharmaceutical Co. Ltd

Treatments:

Nivolumab

Criteria

Inclusion Criteria:

1. Phase 1b part only: Participants with advanced, nonresectable, or recurrent solid
tumor for which no alternative standard therapy or no effective therapy exists
(participants who will be the candidate of treatment by nivolumab monotherapy as
standard therapy is acceptable)

2. Phase 2 part only: Nonresectable specific solid tumor participants with confirmed
diagnosis who showed disease progression by investigator's assessment during or after
1st line chemotherapy and did not receive any other systemic chemotherapy to
advanced/recurrent disease

3. Participants who have accessible tumors for biopsy and agree with tumor biopsy for pre
and post treatment of study drug (If a pre-treatment biopsy cannot be obtained due to
safety issue, then an archival tumor tissue sample may be submitted)

4. Life expectancy of greater than or equal to (>=) 12 weeks

5. Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) 0-1

6. Phase 2 part only: At least one measurable lesion based on RECIST 1.1 (Lesions that
have had radiotherapy or loco-regional therapies must show evidence of progressive
disease to be deemed a measurable lesion)

Exclusion Criteria:

1. Diagnosed with meningeal carcinomatosis

2. Participants with brain or subdural metastases or invasion are not eligible

3. Participants with any active, known, or suspected autoimmune disease