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Solid NeoplasmsPhase 1/2NCT04078295

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

A Phase 1/2 study testing E7389-LF and Nivolumab in people with Solid Neoplasms, run by Eisai Co., Ltd. at 19 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Solid Neoplasms
What is being tested?
E7389-LF and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
19 sitesJapan
Study dates
5 Sep 2019to 31 Mar 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Japan19 sites

  • Eisai Trial Site #11

    Akashi, Hyōgo

  • Eisai Trial Site #6

    Chuo Ku, Osaka

  • Eisai Trial Site #8

    Chuo Ku, Osaka

  • Eisai Trial Site #1

    Chuo Ku, Tokyo

  • Eisai Trial Site #18

    Kashiwa, Chiba

  • Eisai Trial Site #2

    Kashiwa, Chiba

  • Eisai Trial Site #19

    Kitaadachi-gun, Saitama

  • Eisai Trial Site #10

    Koto-Ku, Tokyo

  • Eisai Trial Site #12

    Kōtoku

  • Eisai Trial Site #4

    Kurume, Fukuoka

  • Eisai Trial Site #14

    Matsuya, Ehime

  • Eisai Trial Site #13

    Nagoya, Aichi-ken

  • Eisai Trial Site #5

    Osakasa, Osaka

  • Eisai Trial Site #7

    Sakai C, Osaka

  • Eisai Trial Site #3

    Sendai, Miyagi

  • Eisai Trial Site #17

    Suita, Osaka

  • Eisai Trail Site #16

    Sunto-g, Shizuo

  • Eisai Trial Site #9

    Wakayama, Wakaya

  • Eisai Trial Site #15

    Yokohama, Kanaga

Other trials in Japan

About this study

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

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
Being tested
E7389-LF, Nivolumab
Keywords
E7389 liposomal formulation, Nivolumab, Neoplasms, Solid Tumor
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E7389-LFDrug

    E7389-LF Intravenous infusion.

  • NivolumabDrug

    Also called ONO-4538

    Nivolumab Intravenous infusion.

Study groups in NCT04078295
Study groupRoleWhat they receive
Phase 1b, Cohort 1: E7389-LF Dose 1 + Nivolumab Dose 1ExperimentalParticipants will receive E7389-LF (intravenous) Dose 1 and nivolumab (intravenous) Dose 1 on specified days.
Receives: Drug: E7389-LF; Drug: Nivolumab
Phase 1b, Cohort 2: E7389-LF Dose 2 + Nivolumab Dose 1ExperimentalParticipants will receive E7389-LF (intravenous) Dose 2 and nivolumab (intravenous) Dose 1 on specified days.
Receives: Drug: E7389-LF; Drug: Nivolumab
Phase 1b, Cohort 3: E7389-LF Dose 3 + Nivolumab Dose 2ExperimentalParticipants will receive E7389-LF (intravenous) Dose 3 and nivolumab (intravenous) Dose 2 on specified days.
Receives: Drug: E7389-LF; Drug: Nivolumab
Phase 1b, Cohort 4: E7389-LF Dose 4 + Nivolumab Dose 2ExperimentalParticipants will receive E7389-LF (intravenous) Dose 4 and nivolumab (intravenous) Dose 2 on specified days.
Receives: Drug: E7389-LF; Drug: Nivolumab
Phase 2, Cohort-1: E7389-LF + NivolumabExperimentalParticipants with gastric cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.
Receives: Drug: E7389-LF; Drug: Nivolumab
Phase 2, Cohort-2: E7389-LF + NivolumabExperimentalParticipants with esophageal cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.
Receives: Drug: E7389-LF; Drug: Nivolumab
Phase 2, Cohort-3: E7389-LF + NivolumabExperimentalParticipants with small lung cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.
Receives: Drug: E7389-LF; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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.

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

Secondary outcomes (14)

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

    Measured: 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)

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

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

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

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

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

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

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

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

  6. Phase 1b and 2: Number of Participants With Clinically Significant Abnormal Physical Examination Findings

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

  7. Phase 1b and Phase 2, Cmax: Maximum Observed Plasma Concentration of E7389-LF

    Measured: Phase 1b, Cycle 1 Day 1: 0 to 24 hours, Cycle 1 Days 4 and 8; Phase 2, Cycle 1 Days 1 and 8 (Cycle length = up to 28 days)

  8. Phase 1b and Phase 2: Serum Concentration of Nivolumab

    Measured: Up to Cycle 13 (each Cycle length = up to 28 days)

  9. Phase 1b and Phase 2, Tmax: Time to Maximum Observed Plasma Concentration (Cmax) of E7389-LF

    Measured: Phase 1b, Cycle 1 Day 1: 0 to 24 hours, Cycle 1 Days 4 and 8; Phase 2, Cycle 1 Days 1 and 8 (Cycle length = up to 28 days)

  10. Phase 1b and Phase 2, AUC: Area Under the Plasma Concentration-time Curve Over Time From 0 to Last Measurable Concentration of E7389-LF

    Measured: Phase 1b, Cycle 1 Day 1: 0 to 24 hours, Cycle 1 Days 4 and 8; Phase 2, Cycle 1 Days 1 and 8 (Cycle length = up to 28 days)

  11. Phase 1b and Phase 2, T1/2: Terminal Phase Elimination Half-life of E7389-LF

    Measured: Phase 1b, Cycle 1 Day 1: 0 to 24 hours, Cycle 1 Days 4 and 8; Phase 2, Cycle 1 Days 1 and 8 (Cycle length = up to 28 days)

  12. Phase 1b and Phase 2, CL: Total Body Clearance of E7389-LF

    Measured: Phase 1b, Cycle 1 Day 1: 0 to 24 hours, Cycle 1 Days 4 and 8; Phase 2, Cycle 1 Days 1 and 8 (Cycle length = up to 28 days)

  13. Phase 1b and Phase 2, Vd: Volume of Distribution of E7389-LF

    Measured: Phase 1b, Cycle 1 Day 1: 0 to 24 hours, Cycle 1 Days 4 and 8; Phase 2, Cycle 1 Days 1 and 8 (Cycle length = up to 28 days)

  14. Phase 2: Progression-Free Survival (PFS)

    PFS is defined as the time from the date of the first administration of drug to the date of the first documentation of disease progression or death due to any cause, whichever comes first. The PFS will be assessed by investigator based on RECIST version 1.1.

    Measured: From the first does of the study drug up to the first documentation of disease progression or death due to any cause, whichever comes first (up to approximately 79 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start5 Sep 2019
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04078295
Sponsor's protocol ID
E7389-J081-120
Status last verified
Oct 2026
First submitted
2 Sep 2019
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Publications

  • 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.

    PubMed 39516370

  • 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.

    PubMed 38295160

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing E7389-LF and Nivolumab in people with Solid Neoplasms, run by Eisai Co., Ltd. at 19 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: Baseline up to Cycle 1 (Cycle length is equal to [=] up to 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04078295, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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