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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 : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
ImCheck Therapeutics

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 an approved checkpoint inhibitor (CPI). Part 2 will be a cohort expansion into two solid tumor indications and one hematologic malignancy for ICT01 monotherapy, and one CPI-approved indication receiving ICT01 plus CPI.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Hematopoietic/Lymphoid Cancer Biological: IV ICT01 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-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
Official Title: 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
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
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
Biological: IV ICT01
humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody

Experimental: IV ICT01 + Checkpoint Inhibitor
A range of IV ICT01 doses administered every 3 weeks will be tested in combination with an approved dosing regimen of CPI in Part 1 Dose Escalation and up to 2 dose levels in Part 2 Cohort Expansion
Biological: IV ICT01
humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody




Primary Outcome Measures :
  1. Adverse Events (Parts 1 & 2) [ Time Frame: 6 months ]
    Incidence of treatment-emergent adverse events

  2. Objective Response Rate using RECIST for solid tumor patients (Part 2) [ Time Frame: 6 months ]
    RECIST is measured every 8 weeks during treatment

  3. Objective Response Rate using RECIL for lymphoma patients (Part 2) [ Time Frame: 6 months ]
    RECIL is measured every 8 weeks during treatment


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Cmax following the first dose of ICT01 [ Time Frame: 1 day ]
    PK parameter from serum ICT01 levels

  4. AUC following the first dose of ICT01 [ Time Frame: 21 days ]
    PK parameter from serum ICT01 levels

  5. Clearance at steady-state of ICT01 [ Time Frame: 6 months ]
    PK parameter from serum ICT01 levels

  6. Half-life of ICT01 [ Time Frame: 6 months ]
    PK parameter from serum ICT01 levels

  7. Objective Response Rate using iRECIST for solid tumor patients (Part 2) [ Time Frame: 6 months ]
    iRECIST is measured every 8 weeks during treatment



Information from the National Library of Medicine

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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. 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)

  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

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): NCT04243499


Contacts
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Contact: Paul Frohna, MD, PhD 8582055285 paul.frohna@imcheck.fr

Locations
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Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium
France
Institut Goustave Roussey Not yet recruiting
Paris, France
Principal Investigator: Aurelien Marabelle, MD, PhD         
Sponsors and Collaborators
ImCheck Therapeutics
Investigators
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Study Director: Paul Frohna, MD, PhD ImCheck Therapeutics
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Responsible Party: ImCheck Therapeutics
ClinicalTrials.gov Identifier: NCT04243499    
Other Study ID Numbers: ICT01-101
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
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
Keywords provided by ImCheck Therapeutics:
gamma delta T cells
butyrophilin