IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Biological: IPH5401 and Durvalumab
- Registration Number
- NCT03665129
- Lead Sponsor
- Innate Pharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 73
- Patients with advanced and/or metastatic histologically solid tumors with evidence of active disease, who have been treated with a minimum of one line of systemic therapy in the metastatic setting, and in expansion part, no more than two prior systemic therapies.
- At least 18 years of age.
- ECOG performance status of ≤1.
- Adequate organ function
-
For patients with Non Small Cell Lung Cancer (NSCLC):
a. Known actionable mutation or rearrangement (including but not limited to the epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) gene rearrangements, ROS-1 alterations or BRAF mutations)
-
For patient with Hepatocellular carcinoma (HCC):
- Hepatic encephalopathy in the past 12 months.
- Ascites that requires repeated paracentesis in the past 2 months.
- Main portal vein thrombosis.
- Active or prior history of gastrointestinal bleeding in the past 12 months.
- Prior hepatic transplantation.
-
Patients with known spinal cord compression.
-
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort expansion NSCLC anti-PD-(L)1 pretreated IPH5401 and Durvalumab IPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients Cohort expansion HCC anti-PD-(L)1 pretreated IPH5401 and Durvalumab IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 pretreated patients Dose escalation IPH5401 and Durvalumab IPH5401 at different doses and schedule + Durvalumab Cohort expansion HCC anti-PD-(L)1 naive IPH5401 and Durvalumab IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients
- Primary Outcome Measures
Name Time Method Adverse events (AEs) From screening visit up to 30 days after the last dose of study medication To evaluate the safety profile
Occurrence of Drug Limited Toxicities (DLTs) From Time of First dose assessed up to 6 weeks To assess the occurrence of Drug Limited Toxicities (DLTs)
- Secondary Outcome Measures
Name Time Method Progression Free Survival 2 years and 9 months time between the start of treatment and the first documented progression or death
Objective Response Rate up to 12 months Rate of patients in complete or partial response according to RECIST 1.1
Duration of Response 2 years and 9 months duration between the complete or partial response and the first documented progression
Trial Locations
- Locations (12)
ICAHN School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Centre Hospitalier Universitaire- Hôpital Nord Laennec
🇫🇷Nantes, France
Park Nicollet Frauenshuh Cancer Center
🇺🇸Saint Louis Park, Minnesota, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
NEXT Oncology
🇺🇸San Antonio, Texas, United States
Centre Georges-Francois Leclerc
🇫🇷Dijon, France
Centre Leon Berard
🇫🇷Lyon, France
Institut du Cancer de Montpellier
🇫🇷Montpellier, France
Hôpital de la Timone- AP-HM
🇫🇷Marseille, France
Centre Eugène Marquis
🇫🇷Rennes, France
Institut Gustave Roussy
🇫🇷Villejuif, France
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States