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.
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
Interventions
Drug | Synonyms | Arms |
---|
E7389-LF | | Phase 1b: E7389-LF + Nivolumab |
Nivolumab | ONO-4538 | Phase 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
Name | Type | Description | Interventions |
---|
Phase 1b: E7389-LF + Nivolumab | Experimental | Participants will receive specified doses of E7389-LF (intravenous) and nivolumab (intravenous) on specified days. | |
Phase 2, Cohort-1: E7389-LF + Nivolumab | Experimental | Participants with gastric cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part. | |
Phase 2, Cohort-2: E7389-LF + Nivolumab | Experimental | Participants with esophageal cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part. | |
Phase 2, Cohort-3: E7389-LF + Nivolumab | Experimental | Participants with small cell lung cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part. | |
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: | Recruiting |
Lead Sponsor: | Eisai Co., Ltd. |
Trial Keywords
- E7389 liposomal formulation
- Nivolumab
- Neoplasms
- Solid Tumor
Last Updated
July 7, 2021