study of E7389 liposomal formulation plus Nivolumab in subjects with solid tumor
- Conditions
- Solid Tumor (Phase 2 part: GC, EGC, SCLC)
- Registration Number
- JPRN-jRCT2080224876
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 116
1. Phase 1b part only: subjects with advanced, nonresectable, or recurrent solid tumor for which no alternative standard therapy or no effective therapy exists (subjects who will be the candidate of treatment by nivolumab monotherapy as standard therapy is acceptable).
2. Phase 2 part only: nonresectable GC, EGC or SCLC subjects with confirmed diagnosis who showed disease progression by investigator's assessment during or after 1st line chemotherapy (2nd line chemotherapy for GC) and did not receive any other systemic chemotherapy to advanced/recurrent disease.
3. Subjects who have accessible tumors for biopsy and agree with tumor biopsy for pre and post treatment of study drug.
4. Life expectancy of >=12 weeks
5. 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).
1. Diagnosed with meningeal carcinomatosis.
2. Subjects with brain or subdural metastases or invasion.
3. Subjects with any active, known, or suspected autoimmune disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>To evaluate safety and tolerability and to determine recommended Phase 2 dose (RP2D) in Phase 1b part.<br>To evaluate objective response rate (ORR) of E7389-LF and nivolumab using RP2D in Phase 2 part in each tumor type.
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>progression free survival(Phase2)