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early termination
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation | Experimental | IPH5401 at different doses and schedule + Durvalumab |
|
| Cohort expansion NSCLC anti-PD-(L)1 pretreated | Experimental | IPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients |
|
| Cohort expansion HCC anti-PD-(L)1 naive | Experimental | IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients |
|
| Cohort expansion HCC anti-PD-(L)1 pretreated | Experimental | IPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 pretreated patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPH5401 and Durvalumab | Biological | IPH5401 and durvalumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Drug Limited Toxicities (DLTs) | To assess the occurrence of Drug Limited Toxicities (DLTs) | From Time of First dose assessed up to 6 weeks |
| Adverse events (AEs) | To evaluate the safety profile | From screening visit up to 30 days after the last dose of study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Rate of patients in complete or partial response according to RECIST 1.1 | up to 12 months |
| Duration of Response | duration between the complete or partial response and the first documented progression |
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Inclusion Criteria:
Exclusion Criteria:
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):
Patients with known spinal cord compression.
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States | ||
| Park Nicollet Frauenshuh Cancer Center |
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| ID | Term |
|---|---|
| C000711668 | avdoralimab |
| C000613593 | durvalumab |
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| 2 years and 9 months |
| Progression Free Survival | time between the start of treatment and the first documented progression or death | 2 years and 9 months |
| Saint Louis Park |
| Minnesota |
| 55426 |
| United States |
| ICAHN School of Medicine at Mount Sinai | New York | New York | 10029-6574 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| NEXT Oncology | San Antonio | Texas | 78006 | United States |
| Centre Georges-Francois Leclerc | Dijon | France |
| Centre Leon Berard | Lyon | 69373 | 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 |