Clinical trial · Interventional
A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor
An Open-Label Phase 1b/2 Study of E7389 Liposomal Formulation Plus Nivolumab in Subjects With Solid Tumor
NCT04078295CI-TRIAL-00102963active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Neoplasms | Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E7389-LF | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Phase 1b, Cohort 1: E7389-LF Dose 1 + Nivolumab Dose 1
- description
- Participants will receive E7389-LF (intravenous) Dose 1 and nivolumab (intravenous) Dose 1 on specified days.
- interventionNames
- Drug: E7389-LF
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Phase 1b, Cohort 2: E7389-LF Dose 2 + Nivolumab Dose 1
- description
- Participants will receive E7389-LF (intravenous) Dose 2 and nivolumab (intravenous) Dose 1 on specified days.
- interventionNames
- Drug: E7389-LF
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Phase 1b, Cohort 3: E7389-LF Dose 3 + Nivolumab Dose 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDOshima 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 39516370
- DERIVEDKawazoe 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 38295160