IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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 facts

Study ID

NCT03665129

Run by

Innate Pharma

People needed

73

Starts

2018-09-07

Expected to finish

2021-02-24

Last updated by the study team

2022-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• James Graham Brown Cancer Center — Louisville, Kentucky, United States
• Park Nicollet Frauenshuh Cancer Center — Saint Louis Park, Minnesota, United States
• ICAHN School of Medicine at Mount Sinai — New York, New York, 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
• Hôpital de la Timone- AP-HM — Marseille, France
• Institut du Cancer de Montpellier — Montpellier, France
• Centre Hospitalier Universitaire- Hôpital Nord Laennec — Nantes, France
• Centre Eugène Marquis — Rennes, France
• Institut Gustave Roussy — Villejuif, France

Full record on ClinicalTrials.gov

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