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:

Active, not 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 DurvalumabCohort expansion HCC anti-PD-(L)1 naive

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
  • IPH5401 and Durvalumab
Cohort expansion NSCLC anti-PD-(L)1 pretreatedExperimentalIPH5401 at recommended dose and schedule + Durvalumab in NSCLC anti-PD-(L)1 pretreated patients
  • IPH5401 and Durvalumab
Cohort expansion HCC anti-PD-(L)1 naiveExperimentalIPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 naive patients
  • IPH5401 and Durvalumab
Cohort expansion HCC anti-PD-(L)1 pretreatedExperimentalIPH5401 at recommended dose and schedule + Durvalumab in HCC anti-PD-(L)1 pretreated patients
  • IPH5401 and Durvalumab

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, 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.
      
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:Active, not recruiting
Lead Sponsor:Innate Pharma

Last Updated

January 22, 2021