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

Conditions

• Solid Neoplasms

Eligibility Criteria

Sex

ALL

Age

20 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• E7389-LF — DRUG
  E7389-LF Intravenous infusion.
• Nivolumab — DRUG
  Nivolumab Intravenous infusion.

Study Details

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.

Key Dates

Start date

Sep 5, 2019

Status verified

Nov 2025

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

125 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.

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) ]