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Trial record 1 of 1 for:    ICT01-101
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First-in-Human Study of ICT01 in Patients With Advanced Cancer (EVICTION)

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Hematopoietic/Lymphoid Cancer Biological: IV ICT01 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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
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 : March 2024
Estimated Study Completion Date : June 2024
Arms and Interventions
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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 + 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
 Biological: IV ICT01
humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events (Parts 1 & 2) [ Time Frame: 12 months ]
    Incidence of treatment-emergent adverse events

  2. Disease Control Rate using RECIST for solid tumor patients (Part 2) [ Time Frame: 12 months ]
    RECIST is measured every 8 weeks during treatment

  3. Disease Control Rate using RECIL for lymphoma patients (Part 2) [ Time Frame: 12 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 RECIST for solid tumor patients (Part 2) [ Time Frame: 12 months ]
    RECIST is measured every 8 weeks during treatment


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. 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
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): NCT04243499


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

Locations
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United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06511
Contact: Priscilla Steve       priscilla.steve@yale.edu   
Principal Investigator: Patricia LoRusso, DO,         
United States, Texas
The University of Texas MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Carissa Jurisprudencia       CGjurisprudencia@mdanderson.org   
Principal Investigator: Abishek Maiti, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98133
Contact: Amanda Ramsing-Lund       aramsing@fredhutch.org   
Principal Investigator: Evan Hall, MD         
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium
Contact: Joanna Neto       joana.neto@bordet.be   
Principal Investigator: Christiane Jungels, MD         
France
Institut Paoli-Calmettes Recruiting
Marseille, France
Contact: Julie Karsenty       KARSENTYJ@ipc.unicancer.fr   
Principal Investigator: Norbert Vey, MD         
Gustave Roussy Recruiting
Paris, France
Contact: Manare ALI       Manare.ALI@gustaveroussy.fr   
Principal Investigator: Aurelien Marabelle, MD, PhD         
Germany
University Carl Gustav Carus Clinical Trial Unit Recruiting
Dresden, Germany
Contact: Sophia Tischer       Sophia.Tischer@uniklinikum-dresden.de   
Principal Investigator: Martin Wermke, MD         
Spain
Vall d'Hebron Instiute of Oncology Recruiting
Barcelona, Spain
Contact: Nuria Farras LLansana       nfarras@vhio.net   
Principal Investigator: Elena Garralda, MD         
United Kingdom
Institute of Cancer Research Recruiting
London, United Kingdom
Contact: Robert Daly       robert.daly@icr.ac.uk   
Principal Investigator: Johann de Bono, MD, PhD         
Sponsors and Collaborators
ImCheck Therapeutics
Investigators
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Study Director: Paul Frohna, MD, PhD ImCheck Therapeutics
More Information
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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: December 29, 2023
Last Verified: December 2023
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
pembrolizumab