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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/14/2019
Start Date:September 7, 2018
End Date:June 2021
Contact:Emmanuel MITRY, MD;PhD
Email:Emmanuel.MITRY@innate-pharma.fr
Phone:+33430303030

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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 part 2, 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 NSCLC:

a. Known actionnable 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:

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.
We found this trial at
3
sites
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Lyon, 69008
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Lyon,
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5206 Research Drive
San Antonio, Texas 78240
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San Antonio, TX
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