Advanced Solid Tumors
Conditions
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.
Interventions
BIOLOGICALIPH5401 and Durvalumab
IPH5401 and durvalumab
Sponsors
AstraZeneca
Innate Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Adverse events (AEs) | From screening visit up to 30 days after the last dose of study medication | To evaluate the safety profile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Progression Free Survival | 2 years and 9 months | time between the start of treatment and the first documented progression or death |
Countries
France, United States
Outcome results
None listed