NCT04078295

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_1

Timeline
11mo left

Started Sep 2019

Longer than P75 for phase_1

Geographic Reach
1 country

19 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Sep 2019Mar 2027

First Submitted

Initial submission to the registry

September 2, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

September 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

February 10, 2026

Status Verified

November 1, 2025

Enrollment Period

7.6 years

First QC Date

September 2, 2019

Last Update Submit

February 6, 2026

Conditions

Solid Neoplasms

Keywords

E7389 liposomal formulationNivolumabNeoplasmsSolid Tumor

Outcome Measures

Primary Outcomes (2)

  • Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs)

    DLTs are defined as study drug related adverse events (AEs). Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0).

    Baseline up to Cycle 1 (Cycle length is equal to [=] up to 28 days)

  • Phase 2: ORR

    ORR is defined as the percentage of participants who have best overall response of complete response (CR) or partial response (PR). The ORR will be assessed by investigator based on response evaluation criteria in solid tumors (RECIST) version 1.1.

    Baseline up to End of Treatment (Up to approximately 79 months)

Secondary Outcomes (14)

  • Phase 1b and Phase 2: Number of Participants With AEs and Serious Adverse Events (SAEs)

    Up to 30 days after the last dose of study drug or before initiating post anti-cancer treatment, whichever shorter (up to approximately 79 months)

  • Phase 1b and Phase 2: Number of Participants With Markedly Abnormal Laboratory Evaluations

    Baseline up to End of Treatment (Up to approximately 79 months)

  • Phase 1b and Phase 2: Number of Participants With Markedly Abnormal Vital Signs

    Baseline up to End of Treatment (Up to approximately 79 months)

  • Phase 1b and Phase 2: Number of Participants With Clinically Abnormal 12-lead Electrocardiogram (ECG)

    Baseline up to End of Treatment (Up to approximately 79 months)

  • Phase 1b and Phase 2: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

    Baseline up to End of Treatment (Up to approximately 79 months)

  • +9 more secondary outcomes

Study Arms (7)

Phase 1b, Cohort 1: E7389-LF Dose 1 + Nivolumab Dose 1

EXPERIMENTAL

Participants will receive E7389-LF (intravenous) Dose 1 and nivolumab (intravenous) Dose 1 on specified days.

Drug: E7389-LFDrug: Nivolumab

Phase 1b, Cohort 2: E7389-LF Dose 2 + Nivolumab Dose 1

EXPERIMENTAL

Participants will receive E7389-LF (intravenous) Dose 2 and nivolumab (intravenous) Dose 1 on specified days.

Drug: E7389-LFDrug: Nivolumab

Phase 1b, Cohort 3: E7389-LF Dose 3 + Nivolumab Dose 2

EXPERIMENTAL

Participants will receive E7389-LF (intravenous) Dose 3 and nivolumab (intravenous) Dose 2 on specified days.

Drug: E7389-LFDrug: Nivolumab

Phase 1b, Cohort 4: E7389-LF Dose 4 + Nivolumab Dose 2

EXPERIMENTAL

Participants will receive E7389-LF (intravenous) Dose 4 and nivolumab (intravenous) Dose 2 on specified days.

Drug: E7389-LFDrug: Nivolumab

Phase 2, Cohort-1: E7389-LF + Nivolumab

EXPERIMENTAL

Participants with gastric cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.

Drug: E7389-LFDrug: Nivolumab

Phase 2, Cohort-2: E7389-LF + Nivolumab

EXPERIMENTAL

Participants with esophageal cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.

Drug: E7389-LFDrug: Nivolumab

Phase 2, Cohort-3: E7389-LF + Nivolumab

EXPERIMENTAL

Participants with small lung cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.

Drug: E7389-LFDrug: Nivolumab

Interventions

E7389-LFDRUG

E7389-LF Intravenous infusion.

Phase 1b, Cohort 1: E7389-LF Dose 1 + Nivolumab Dose 1Phase 1b, Cohort 2: E7389-LF Dose 2 + Nivolumab Dose 1Phase 1b, Cohort 3: E7389-LF Dose 3 + Nivolumab Dose 2Phase 1b, Cohort 4: E7389-LF Dose 4 + Nivolumab Dose 2Phase 2, Cohort-1: E7389-LF + NivolumabPhase 2, Cohort-2: E7389-LF + NivolumabPhase 2, Cohort-3: E7389-LF + Nivolumab
NivolumabDRUG

Nivolumab Intravenous infusion.

Also known as: ONO-4538
Phase 1b, Cohort 1: E7389-LF Dose 1 + Nivolumab Dose 1Phase 1b, Cohort 2: E7389-LF Dose 2 + Nivolumab Dose 1Phase 1b, Cohort 3: E7389-LF Dose 3 + Nivolumab Dose 2Phase 1b, Cohort 4: E7389-LF Dose 4 + Nivolumab Dose 2Phase 2, Cohort-1: E7389-LF + NivolumabPhase 2, Cohort-2: E7389-LF + NivolumabPhase 2, Cohort-3: E7389-LF + Nivolumab

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Phase 2 part only: Participants with a confirmed diagnosis of nonresectable gastric cancer (GC), esophageal cancer (EGC) or small cell lung cancer (SCLC) who showed disease progression based on investigator's assessment during or after first line chemotherapy (second-line chemotherapy for GC) and did not receive any other systemic chemotherapy to advanced/recurrent disease
  • Participants who meet the following criteria for biopsy; Phase 1b part: Participants who have accessible tumors for biopsy and agree to 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.) Phase 2 part: Participants who have accessible tumors for biopsy and agree with tumor biopsy for pre and post treatment of study drug (As an alternative to pre-treatment biopsy, tumor tissue sample taken from recurrent or advanced disease may be submitted). However, if the sponsor and the investigator discuss and agree in advance, and the participants agree to submission of archival tumor tissue, then these participants are eligible regardless of accessible tumors, and consent to biopsy is not necessary
  • Life expectancy of greater than or equal to (\>=) 12 weeks
  • Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) 0-1
  • 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)

You may not qualify if:

  • Diagnosed with meningeal carcinomatosis
  • Participants with brain or subdural metastases or invasion are not eligible
  • Active, known, or suspected autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Eisai Trial Site #13

Nagoya, Aichi-ken, Japan

Location

Eisai Trial Site #18

Kashiwa, Chiba, Japan

Location

Eisai Trial Site #2

Kashiwa, Chiba, Japan

Location

Eisai Trial Site #14

Matsuya, Ehime, Japan

Location

Eisai Trial Site #4

Kurume, Fukuoka, Japan

Location

Eisai Trial Site #11

Akashi, Hyōgo, Japan

Location

Eisai Trial Site #15

Yokohama, Kanaga, Japan

Location

Eisai Trial Site #3

Sendai, Miyagi, Japan

Location

Eisai Trial Site #6

Chuo Ku, Osaka, Japan

Location

Eisai Trial Site #8

Chuo Ku, Osaka, Japan

Location

Eisai Trial Site #5

Osakasa, Osaka, Japan

Location

Eisai Trial Site #7

Sakai C, Osaka, Japan

Location

Eisai Trial Site #17

Suita, Osaka, Japan

Location

Eisai Trial Site #19

Kitaadachi-gun, Saitama, Japan

Location

Eisai Trail Site #16

Sunto-g, Shizuo, Japan

Location

Eisai Trial Site #1

Chuo Ku, Tokyo, Japan

Location

Eisai Trial Site #10

Koto-Ku, Tokyo, Japan

Location

Eisai Trial Site #9

Wakayama, Wakaya, Japan

Location

Eisai Trial Site #12

Kōtoku, Japan

Location

Related Publications (2)

  • Oshima T, Yamamoto S, Kawakami H, Makino T, Kawazoe A, Masuishi T, Tsushima T, Hirao M, Tsuda M, Hino K, Yamamoto N, Hara H, Kaname S, Matsuoka D, Otake Y, Yasuda K, Takase T, Takashima S, Semba T, Ooki A. Phase 1b/2 study of the liposomal formulation of eribulin (E7389-LF) in combination with nivolumab: Results from the phase 2 esophageal cancer cohort. BJC Rep. 2024 Sep 4;2(1):66. doi: 10.1038/s44276-024-00066-6.

    PMID: 39516370DERIVED

  • Kawazoe A, Yamamoto N, Sugimoto N, Kawakami H, Oshima T, Yamaguchi K, Hino K, Hirao M, Kurokawa Y, Kawakami T, Tsuda M, Hara H, Kaname S, Matsuoka D, Otake Y, Yasuda K, Takase T, Takashima S, Semba T, Muro K. Phase II Study of the Liposomal Formulation of Eribulin (E7389-LF) in Combination with Nivolumab: Results from the Gastric Cancer Cohort. Clin Cancer Res. 2024 Apr 1;30(7):1264-1272. doi: 10.1158/1078-0432.CCR-23-1768.

    PMID: 38295160DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2019

First Posted

September 6, 2019

Study Start

September 5, 2019

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

February 10, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Locations

JP(19)