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

A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors

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.

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.