A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor
NCT ID: NCT04078295
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
125 participants
INTERVENTIONAL
2019-09-05
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1b, Cohort 1: E7389-LF Dose 1 + Nivolumab Dose 1
Participants will receive E7389-LF (intravenous) Dose 1 and nivolumab (intravenous) Dose 1 on specified days.
E7389-LF
E7389-LF Intravenous infusion.
Nivolumab
Nivolumab Intravenous infusion.
Phase 1b, Cohort 2: E7389-LF Dose 2 + Nivolumab Dose 1
Participants will receive E7389-LF (intravenous) Dose 2 and nivolumab (intravenous) Dose 1 on specified days.
E7389-LF
E7389-LF Intravenous infusion.
Nivolumab
Nivolumab Intravenous infusion.
Phase 1b, Cohort 3: E7389-LF Dose 3 + Nivolumab Dose 2
Participants will receive E7389-LF (intravenous) Dose 3 and nivolumab (intravenous) Dose 2 on specified days.
E7389-LF
E7389-LF Intravenous infusion.
Nivolumab
Nivolumab Intravenous infusion.
Phase 1b, Cohort 4: E7389-LF Dose 4 + Nivolumab Dose 2
Participants will receive E7389-LF (intravenous) Dose 4 and nivolumab (intravenous) Dose 2 on specified days.
E7389-LF
E7389-LF Intravenous infusion.
Nivolumab
Nivolumab Intravenous infusion.
Phase 2, Cohort-1: E7389-LF + Nivolumab
Participants with gastric cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.
E7389-LF
E7389-LF Intravenous infusion.
Nivolumab
Nivolumab Intravenous infusion.
Phase 2, Cohort-2: E7389-LF + Nivolumab
Participants with esophageal cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.
E7389-LF
E7389-LF Intravenous infusion.
Nivolumab
Nivolumab Intravenous infusion.
Phase 2, Cohort-3: E7389-LF + Nivolumab
Participants with small lung cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.
E7389-LF
E7389-LF Intravenous infusion.
Nivolumab
Nivolumab Intravenous infusion.
Interventions
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E7389-LF
E7389-LF Intravenous infusion.
Nivolumab
Nivolumab Intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Participants with brain or subdural metastases or invasion are not eligible
3. Active, known, or suspected autoimmune disease
20 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Eisai Trial Site #13
Nagoya, Aichi-ken, Japan
Eisai Trial Site #18
Kashiwa, Chiba, Japan
Eisai Trial Site #2
Kashiwa, Chiba, Japan
Eisai Trial Site #14
Matsuya, Ehime, Japan
Eisai Trial Site #4
Kurume, Fukuoka, Japan
Eisai Trial Site #11
Akashi, Hyōgo, Japan
Eisai Trial Site #15
Yokohama, Kanaga, Japan
Eisai Trial Site #3
Sendai, Miyagi, Japan
Eisai Trial Site #6
Chuo Ku, Osaka, Japan
Eisai Trial Site #8
Chuo Ku, Osaka, Japan
Eisai Trial Site #5
Osakasa, Osaka, Japan
Eisai Trial Site #7
Sakai C, Osaka, Japan
Eisai Trial Site #17
Suita, Osaka, Japan
Eisai Trial Site #19
Kitaadachi-gun, Saitama, Japan
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 #9
Wakayama, Wakaya, Japan
Eisai Trial Site #12
Kōtoku, , Japan
Countries
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References
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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.
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.
Other Identifiers
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E7389-J081-120
Identifier Type: -
Identifier Source: org_study_id
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