Clinical Trials /

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

NCT03665129

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.

Related Conditions:
  • Hepatocellular Carcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
IPH5401 and DurvalumabDose 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

NameTypeDescriptionInterventions
Dose escalationExperimentalIPH5401 at different doses and schedule + Durvalumab
    Cohort expansion NSCLCExperimentalIPH5401 at recommended dose and schedule + Durvalumab in NSCLC patients
      Cohort expansion HCCExperimentalIPH5401 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

        Last Updated