Clinical Trials /

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

NCT04078295

Description:

The primary purpose of the study is to evaluate safety and tolerability and to determine recommended Phase 2 dose (RP2D) of E7389-LF in combination with nivolumab in Phase 1b part, and to evaluate objective response rate (ORR) of E7389-LF and nivolumab using RP2D in Phase 2 part in each tumor type.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor
  • Official Title: An Open-Label Phase 1b/2 Study of E7389 Liposomal Formulation Plus Nivolumab in Subjects With Solid Tumor

Clinical Trial IDs

  • ORG STUDY ID: E7389-J081-120
  • NCT ID: NCT04078295

Conditions

  • Solid Neoplasms

Interventions

DrugSynonymsArms
E7389-LFPhase 1b: E7389-LF + Nivolumab
NivolumabONO-4538Phase 1b: E7389-LF + Nivolumab

Purpose

The primary purpose of the study is to evaluate safety and tolerability and to determine recommended Phase 2 dose (RP2D) of E7389-LF in combination with nivolumab in Phase 1b part, and to evaluate objective response rate (ORR) of E7389-LF and nivolumab using RP2D in Phase 2 part in each tumor type.

Trial Arms

NameTypeDescriptionInterventions
Phase 1b: E7389-LF + NivolumabExperimentalParticipants will receive specified doses of E7389-LF (intravenous) and nivolumab (intravenous) on specified days.
  • E7389-LF
  • Nivolumab
Phase 2, Cohort-1: E7389-LF + NivolumabExperimentalParticipants will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.
  • E7389-LF
  • Nivolumab
Phase 2, Cohort-2: E7389-LF + NivolumabExperimentalParticipants will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.
  • E7389-LF
  • Nivolumab
Phase 2, Cohort-3: E7389-LF + NivolumabExperimentalParticipants will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.
  • E7389-LF
  • Nivolumab

Eligibility Criteria

        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: Nonresectable specific solid tumor participants with confirmed
             diagnosis who showed disease progression by investigator's assessment during or after
             1st line chemotherapy and did not receive any other systemic chemotherapy to
             advanced/recurrent disease

          3. Participants who have accessible tumors for biopsy and agree with 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)

          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. Participants with any active, known, or suspected autoimmune disease
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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)
Safety Issue:
Description: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).

Secondary Outcome Measures

Measure: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 36 Months)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure:Phase 1b and Phase 2: Serum Concentration of Nivolumab
Time Frame:Up to 36 Months
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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 36 Months)
Safety Issue:
Description: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.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eisai Co., Ltd.

Trial Keywords

  • E7389 liposomal formulation
  • Nivolumab
  • Neoplasms
  • Solid Tumor

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