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

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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

Tracking Information
First Submitted Date  ICMJE September 1, 2018
First Posted Date  ICMJE September 11, 2018
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE September 7, 2018
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • 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)
  • Adverse events (AEs) [ Time Frame: From screening visit up to 30 days after the last dose of study medication ]
    To evaluate the safety profile
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03665129 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • Objective Response Rate [ Time Frame: up to 12 months ]
    Rate of patients in complete or partial response according to RECIST 1.1
  • Duration of Response [ Time Frame: 2 years and 9 months ]
    duration between the complete or partial response and the first documented progression
  • Progression Free Survival [ Time Frame: 2 years and 9 months ]
    time between the start of treatment and the first documented progression or death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Biological: IPH5401 and Durvalumab
IPH5401 and durvalumab
Study Arms  ICMJE
  • Experimental: Dose escalation
    IPH5401 at different doses and schedule + Durvalumab
    Intervention: Biological: IPH5401 and Durvalumab
  • Experimental: Cohort expansion NSCLC
    IPH5401 at recommended dose and schedule + Durvalumab in NSCLC patients
    Intervention: Biological: IPH5401 and Durvalumab
  • Experimental: Cohort expansion HCC
    IPH5401 at recommended dose and schedule in HCC patients
    Intervention: Biological: IPH5401 and Durvalumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emmanuel MITRY, MD;PhD +33430303030 Emmanuel.MITRY@innate-pharma.fr
Contact: Delphine Marie Delphine.Marie@innate-pharma.fr
Listed Location Countries  ICMJE France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03665129
Other Study ID Numbers  ICMJE IPH5401-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Innate Pharma
Study Sponsor  ICMJE Innate Pharma
Collaborators  ICMJE MedImmune LLC
Investigators  ICMJE Not Provided
PRS Account Innate Pharma
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP