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

First listed

Sep 6, 2019

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) ]