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New combo therapy shows promise for Hard-to-Treat cancers

NCT ID NCT04078295

Disease control Sponsor: Eisai Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug combination (E7389 liposomal formulation plus nivolumab) in 125 people with advanced solid tumors that have not responded to standard treatments. The goal is to find the safest dose and see if the combination can shrink tumors. The study is for people with certain cancers like gastric, esophageal, or small cell lung cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

125 people

The number who actually took part.

Started

Sep 2019

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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 3. 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 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. Active, known, or suspected autoimmune disease

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Conditions

The condition(s) this trial relates to.

esophageal cancer gastric cancer neoplasm small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid neoplasms

Contacts and locations

Locations

  • 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 #11

    Akashi, Hyōgo, Japan

  • Eisai Trial Site #12

    Kōtoku, Japan

  • Eisai Trial Site #13

    Nagoya, Aichi-ken, Japan

  • Eisai Trial Site #14

    Matsuya, Ehime, Japan

  • Eisai Trial Site #15

    Yokohama, Kanaga, Japan

  • Eisai Trial Site #17

    Suita, Osaka, Japan

  • Eisai Trial Site #18

    Kashiwa, Chiba, Japan

  • Eisai Trial Site #19

    Kitaadachi-gun, Saitama, Japan

  • Eisai Trial Site #2

    Kashiwa, Chiba, Japan

  • Eisai Trial Site #3

    Sendai, Miyagi, Japan

  • Eisai Trial Site #4

    Kurume, Fukuoka, Japan

  • Eisai Trial Site #5

    Osakasa, Osaka, Japan

  • Eisai Trial Site #6

    Chuo Ku, Osaka, Japan

  • Eisai Trial Site #7

    Sakai C, Osaka, Japan

  • Eisai Trial Site #8

    Chuo Ku, Osaka, Japan

  • Eisai Trial Site #9

    Wakayama, Wakaya, Japan

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