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First-in-Human Study of ICT01 in Patients With Advanced Cancer (EVICTION)

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: NCT04243499
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : December 29, 2023
Sponsor:
Information provided by (Responsible Party):
ImCheck Therapeutics

Tracking Information
First Submitted Date  ICMJE January 24, 2020
First Posted Date  ICMJE January 28, 2020
Last Update Posted Date December 29, 2023
Actual Study Start Date  ICMJE February 10, 2020
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2022)
  • Adverse Events (Parts 1 & 2) [ Time Frame: 12 months ]
    Incidence of treatment-emergent adverse events
  • Disease Control Rate using RECIST for solid tumor patients (Part 2) [ Time Frame: 12 months ]
    RECIST is measured every 8 weeks during treatment
  • Disease Control Rate using RECIL for lymphoma patients (Part 2) [ Time Frame: 12 months ]
    RECIL is measured every 8 weeks during treatment
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
  • Adverse Events (Parts 1 & 2) [ Time Frame: 6 months ]
    Incidence of treatment-emergent adverse events
  • Objective Response Rate using RECIST for solid tumor patients (Part 2) [ Time Frame: 6 months ]
    RECIST is measured every 8 weeks during treatment
  • Objective Response Rate using RECIL for lymphoma patients (Part 2) [ Time Frame: 6 months ]
    RECIL is measured every 8 weeks during treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2022)
  • Change from Baseline in the Number of Circulating Gamma Delta T Cells [ Time Frame: 28 days ]
    Flow cytometric counting of circulating gamma delta T cells
  • Change from Baseline in the Activation State of Circulating Gamma Delta T Cells [ Time Frame: 28 days ]
    Flow cytometric measurement of CD69 and Ki67 expression on gamma delta T cells
  • Cmax following the first dose of ICT01 [ Time Frame: 1 day ]
    PK parameter from serum ICT01 levels
  • AUC following the first dose of ICT01 [ Time Frame: 21 days ]
    PK parameter from serum ICT01 levels
  • Clearance at steady-state of ICT01 [ Time Frame: 6 months ]
    PK parameter from serum ICT01 levels
  • Half-life of ICT01 [ Time Frame: 6 months ]
    PK parameter from serum ICT01 levels
  • Objective Response Rate using RECIST for solid tumor patients (Part 2) [ Time Frame: 12 months ]
    RECIST is measured every 8 weeks during treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
  • Change from Baseline in the Number of Circulating Gamma Delta T Cells [ Time Frame: 28 days ]
    Flow cytometric counting of circulating gamma delta T cells
  • Change from Baseline in the Activation State of Circulating Gamma Delta T Cells [ Time Frame: 28 days ]
    Flow cytometric measurement of CD69 and Ki67 expression on gamma delta T cells
  • Cmax following the first dose of ICT01 [ Time Frame: 1 day ]
    PK parameter from serum ICT01 levels
  • AUC following the first dose of ICT01 [ Time Frame: 21 days ]
    PK parameter from serum ICT01 levels
  • Clearance at steady-state of ICT01 [ Time Frame: 6 months ]
    PK parameter from serum ICT01 levels
  • Half-life of ICT01 [ Time Frame: 6 months ]
    PK parameter from serum ICT01 levels
  • Objective Response Rate using iRECIST for solid tumor patients (Part 2) [ Time Frame: 6 months ]
    iRECIST is measured every 8 weeks during treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-in-Human Study of ICT01 in Patients With Advanced Cancer
Official Title  ICMJE A First-in-human, Two-part Clinical Study to Assess the Safety, Tolerability and Activity of IV Doses of ICT01 as Monotherapy and in Combination With a Checkpoint Inhibitor, in Patients With Advanced-stage, Relapsed/Refractory Cancer
Brief Summary Part 1 will be a dose escalation study of IV ICT01 (a monoclonal antibody targeting BTN3A) as monotherapy in patients with advanced solid or hematologic tumors, followed by a cohort examining the combination of ICT01 plus pembrolizumab (Keytruda). Part 2 will be a cohort expansion into 2 solid tumor indications and one hematologic malignancy for ICT01 monotherapy, and 3 solid tumor indications for the combination of ICT01 plus pembrolizumab.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients will be assigned to a dose level of ICT01 at the time of their enrollment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor, Adult
  • Hematopoietic/Lymphoid Cancer
Intervention  ICMJE Biological: IV ICT01
humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody
Study Arms  ICMJE
  • Experimental: IV ICT01 Monotherapy
    Up to six ICT01 dose levels administered as IV monotherapy every 3 weeks will be tested in Part 1 Dose Escalation and up to 2 dose levels in Part 2 Cohort Expansion
    Intervention: Biological: IV ICT01
  • Experimental: IV ICT01 + IV Pembrolizumab
    A range of IV ICT01 doses administered every 3 weeks will be tested in combination with 200 mg pembrolizumab in Part 1 Dose Escalation and up to 2 dose levels of ICT01 plus 200 mg pembrolizumab in Part 2 Cohort Expansion
    Intervention: Biological: IV ICT01
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: January 24, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Voluntarily signed informed consent form.
  2. Relapsed/refractory patients with histologically or cytologically confirmed diagnosis of advanced-stage or recurrent cancer, including:

    Group A: bladder, breast, colon, gastric, melanoma, ovarian, prostate and PDAC Group B: hematologic malignancies including acute myeloid leukemia, acute lymphocytic leukemia, Diffuse large B cell lymphoma and follicular lymphoma Group C: melanoma, cervical, bladder, gastric, head and neck SCC, and lymphoma (according to the approved package labeling of the ICI) Part 2, Group D: Ovarian cancer (2L/3L) with baseline g9d2 T cells > 20K Part 2, Group E: metastatic castrate resistant prostate cancer (2L/3L) with baseline g9d2 T cells > 20K Part 2, Group F: newly diagnosed AML starting venetoclax/azacitidine Part 2, Group G: checkpoint-refractory metastatic melanoma with g9d2 T cells >5K Part 2, Group H: chemotx-refractory or Pt-ineligible urotherlial cancer (bladder) with g9d2 T cells >5K Part 2, Group I: checkpoint-refractory, metastatic HNSCC with g9d2 T cells >5K

  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  4. Life expectancy > 3 months as assessed by the Investigator
  5. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts

Exclusion Criteria:

  1. Any malignancy of Vγ9Vδ2 T cell origin
  2. Any anti-tumor-directed drug therapy within 28 days or 5 times the elimination half-life (whichever is shorter) before study treatment (does not apply to patients receiving ICI for the combination arm)
  3. Treatment with investigational drug(s) within 28 days before study treatment
  4. Systemic steroids at a daily dose of > 10 mg of prednisone, > 2 mg of dexamethasone or equivalent, for the last 28 days and need for ongoing treatment.
  5. Patients with rapidly progressing disease defined as advanced/metastatic, symptomatic, visceral spread, with a risk of life-threatening complications in the short term (e.g., during Screening Period/ treatment washout) that includes patients with massive uncontrolled effusions pleural, pericardial, peritoneal, pulmonary lymphangitis, and over 50% liver involvement
  6. Ongoing immune-related adverse events (irAEs) and/or AEs ≥grade 2 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with replacement hormone therapy.
  7. Within 4 weeks of major surgery
  8. Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
  9. Primary or secondary immune deficiency
  10. Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
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: Paul Frohna, MD, PhD 8582055285 paul.frohna@imcheck.fr
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04243499
Other Study ID Numbers  ICMJE ICT01-101
Has Data Monitoring Committee Yes
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
Current Responsible Party ImCheck Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ImCheck Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul Frohna, MD, PhD ImCheck Therapeutics
PRS Account ImCheck Therapeutics
Verification Date December 2023

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