IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors
Part of paid clinical trials in Louisville, Kentucky.
- Sponsor
- Innate Pharma
- Study ID
- NCT03665129
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Advanced Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- IPH5401 and Durvalumab — BIOLOGICALIPH5401 and durvalumab
Study Details
This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of IPH5401 (anti C5aR) in combination with Durvalumab (MEDI4736) in Adult Subjects with selected advanced solid tumors.
Key Dates
- Start date
- Sep 7, 2018
- Status verified
- Jan 2022
- Primary completion
- Feb 24, 2021
- Completion
- Feb 24, 2021
Study Design
- Enrollment
- 73 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Dose escalationIPH5401 at different doses and schedule + Durvalumab
- Experimental: Cohort expansion NSCLC anti-PD-(L)1 pretreatedIPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients
- Experimental: Cohort expansion HCC anti-PD-(L)1 naiveIPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients
- Experimental: Cohort expansion HCC anti-PD-(L)1 pretreatedIPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 pretreated patients
Primary Outcome Measure
Occurrence of Drug Limited Toxicities (DLTs) [ Time Frame: From Time of First dose assessed up to 6 weeks ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | - |
| Park Nicollet Frauenshuh Cancer Center | Saint Louis Park | Minnesota | 55426 | - |
| ICAHN School of Medicine at Mount Sinai | New York | New York | 10029-6574 | - |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | - |
| NEXT Oncology | San Antonio | Texas | 78006 | - |
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