Clinical trial NCT03665129: IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors
Official title: A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Innate Pharma
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2018-09-11
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. At least 18 years of age.
3. ECOG performance status of ≤1.
4. Adequate organ function

Exclusion Criteria:

1. 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)
2. For patient with Hepatocellular carcinoma (HCC):

   1. Hepatic encephalopathy in the past 12 months.
   2. Ascites that requires repeated paracentesis in the past 2 months.
   3. Main portal vein thrombosis.
   4. Active or prior history of gastrointestinal bleeding in the past 12 months.
   5. Prior hepatic transplantation.
3. Patients with known spinal cord compression.
4. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Primary outcomes:
measure: Occurrence of Drug Limited Toxicities (DLTs)
timeFrame: From Time of First dose assessed up to 6 weeks
measure: Adverse events (AEs)
timeFrame: From screening visit up to 30 days after the last dose of study medication
Secondary outcomes:
measure: Objective Response Rate
timeFrame: up to 12 months
measure: Duration of Response
timeFrame: 2 years and 9 months
measure: Progression Free Survival
timeFrame: 2 years and 9 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Saint Louis Park
country: United States
facility: Park Nicollet Frauenshuh Cancer Center
state: Minnesota
city: New York
country: United States
facility: ICAHN School of Medicine at Mount Sinai
state: New York
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
city: Dijon
country: France
facility: Centre Georges-Francois Leclerc
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Hôpital de la Timone- AP-HM
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier
city: Nantes
country: France
facility: Centre Hospitalier Universitaire- Hôpital Nord Laennec
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: