Trials / Active Not Recruiting
Active Not RecruitingNCT04078295
A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor
An Open-Label Phase 1b/2 Study of E7389 Liposomal Formulation Plus Nivolumab in Subjects With Solid Tumor
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E7389-LF | E7389-LF Intravenous infusion. |
| DRUG | Nivolumab | Nivolumab Intravenous infusion. |
Timeline
- Start date
- 2019-09-05
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
- First posted
- 2019-09-06
- Last updated
- 2026-02-10
Locations
19 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT04078295. Inclusion in this directory is not an endorsement.