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

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 escalation
    IPH5401 at different doses and schedule + Durvalumab
  • Experimental: Cohort expansion NSCLC anti-PD-(L)1 pretreated
    IPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients
  • Experimental: Cohort expansion HCC anti-PD-(L)1 naive
    IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients
  • Experimental: Cohort expansion HCC anti-PD-(L)1 pretreated
    IPH5401 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)

FacilityCityStateZIPSite coordinators
James Graham Brown Cancer CenterLouisvilleKentucky40202-
Park Nicollet Frauenshuh Cancer CenterSaint Louis ParkMinnesota55426-
ICAHN School of Medicine at Mount SinaiNew YorkNew York10029-6574-
Sarah Cannon Research InstituteNashvilleTennessee37203-
NEXT OncologySan AntonioTexas78006-

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