Description:
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.
Title
- Brief Title: IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors
- Official Title: A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
IPH5401-101
- NCT ID:
NCT03665129
Conditions
Interventions
Drug | Synonyms | Arms |
---|
IPH5401 and Durvalumab | | Dose escalation |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose escalation | Experimental | IPH5401 at different doses and schedule + Durvalumab | |
Cohort expansion NSCLC | Experimental | IPH5401 at recommended dose and schedule + Durvalumab in NSCLC patients | |
Cohort expansion HCC | Experimental | IPH5401 at recommended dose and schedule in HCC patients | |
Eligibility Criteria
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 but no more than three prior systemic therapies (for part 1
dose escalation), or no more than two prior systemic therapies (for part 2 cohorts
expansion).
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 mutation in 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Occurrence of Drug Limited Toxicities (DLTs) |
Time Frame: | From Time of First dose assessed up to 6 weeks |
Safety Issue: | |
Description: | To assess the occurrence of Drug Limited Toxicities (DLTs) |
Secondary Outcome Measures
Measure: | Objective Response Rate |
Time Frame: | up to 12 months |
Safety Issue: | |
Description: | Rate of patients in complete or partial response according to RECIST 1.1 |
Measure: | Duration of Response |
Time Frame: | 2 years and 9 months |
Safety Issue: | |
Description: | duration between the complete or partial response and the first documented progression |
Measure: | Progression Free Survival |
Time Frame: | 2 years and 9 months |
Safety Issue: | |
Description: | time between the start of treatment and the first documented progression or death |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Innate Pharma |
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