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Active, Not Recruiting

NCT Number: NCT04078295

A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Solid Neoplasms Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Eisai Trial Site #13, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

E7389-LF

Drug

E7389-LF Intravenous infusion.

Nivolumab

Drug

Nivolumab Intravenous infusion.

Other names: ONO-4538

Primary outcomes

  1. 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)

    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).

  2. Phase 2: ORR

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

    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.

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Sep 6, 2019
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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