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IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors (STELLAR-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03665129
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
Innate Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: IPH5401 and Durvalumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 7, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose escalation
IPH5401 at different doses and schedule + Durvalumab
 Biological: IPH5401 and Durvalumab
IPH5401 and durvalumab
Experimental: Cohort expansion NSCLC
IPH5401 at recommended dose and schedule + Durvalumab in NSCLC patients
 Biological: IPH5401 and Durvalumab
IPH5401 and durvalumab
Experimental: Cohort expansion HCC
IPH5401 at recommended dose and schedule in HCC patients
 Biological: IPH5401 and Durvalumab
IPH5401 and durvalumab


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of Drug Limited Toxicities (DLTs) [ Time Frame: From Time of First dose assessed up to 6 weeks ]
    To assess the occurrence of Drug Limited Toxicities (DLTs)

  2. Adverse events (AEs) [ Time Frame: From screening visit up to 30 days after the last dose of study medication ]
    To evaluate the safety profile


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: up to 12 months ]
    Rate of patients in complete or partial response according to RECIST 1.1

  2. Duration of Response [ Time Frame: 2 years and 9 months ]
    duration between the complete or partial response and the first documented progression

  3. Progression Free Survival [ Time Frame: 2 years and 9 months ]
    time between the start of treatment and the first documented progression or death


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 part 2, 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 NSCLC:

    a. Known actionnable 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:

    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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665129


Contacts
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Contact: Emmanuel MITRY, MD;PhD +33430303030 Emmanuel.MITRY@innate-pharma.fr
Contact: Delphine Marie Delphine.Marie@innate-pharma.fr

Locations
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United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Johanna C Bendell, MD         
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78006
Contact: Anthony Tolcher, MD         
France
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Philippe Cassier, MD         
Institut Gustave Roussy Recruiting
Villejuif, France
Contact: Christophe Massard, MD         
Sponsors and Collaborators
Innate Pharma
MedImmune LLC
More Information
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Responsible Party: Innate Pharma
ClinicalTrials.gov Identifier: NCT03665129     History of Changes
Other Study ID Numbers: IPH5401-101
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Durvalumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs