Clinical Trials /

First-in-Human Study of ICT01 in Patients With Advanced Cancer

NCT04243499

Description:

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 2-3 solid tumor indications and one hematologic malignancy for ICT01 monotherapy, and 1-2 solid tumor indication receiving ICT01 plus pembrolizumab.

Related Conditions:
  • Bladder Carcinoma
  • Breast Carcinoma
  • Cervical Carcinoma
  • Colon Carcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Hematopoietic and Lymphoid Malignancy
  • Melanoma
  • Ovarian Carcinoma
  • Pancreatic Carcinoma
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: First-in-Human Study of ICT01 in Patients With Advanced Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: ICT01-101
  • NCT ID: NCT04243499

Conditions

  • Solid Tumor, Adult
  • Hematopoietic/Lymphoid Cancer

Interventions

DrugSynonymsArms
IV ICT01IV ICT01 + IV Pembrolizumab

Purpose

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 2-3 solid tumor indications and one hematologic malignancy for ICT01 monotherapy, and 1-2 solid tumor indication receiving ICT01 plus pembrolizumab.

Trial Arms

NameTypeDescriptionInterventions
IV ICT01 MonotherapyExperimentalUp 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
  • IV ICT01
IV ICT01 + IV PembrolizumabExperimentalA 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
  • IV ICT01

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse Events (Parts 1 & 2)
Time Frame:6 months
Safety Issue:
Description:Incidence of treatment-emergent adverse events

Secondary Outcome Measures

Measure:Change from Baseline in the Number of Circulating Gamma Delta T Cells
Time Frame:28 days
Safety Issue:
Description:Flow cytometric counting of circulating gamma delta T cells
Measure:Change from Baseline in the Activation State of Circulating Gamma Delta T Cells
Time Frame:28 days
Safety Issue:
Description:Flow cytometric measurement of CD69 and Ki67 expression on gamma delta T cells
Measure:Cmax following the first dose of ICT01
Time Frame:1 day
Safety Issue:
Description:PK parameter from serum ICT01 levels
Measure:AUC following the first dose of ICT01
Time Frame:21 days
Safety Issue:
Description:PK parameter from serum ICT01 levels
Measure:Clearance at steady-state of ICT01
Time Frame:6 months
Safety Issue:
Description:PK parameter from serum ICT01 levels
Measure:Half-life of ICT01
Time Frame:6 months
Safety Issue:
Description:PK parameter from serum ICT01 levels
Measure:Objective Response Rate using iRECIST for solid tumor patients (Part 2)
Time Frame:6 months
Safety Issue:
Description:iRECIST is measured every 8 weeks during treatment

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:ImCheck Therapeutics

Trial Keywords

  • gamma delta T cells
  • butyrophilin
  • pembrolizumab

Last Updated

April 27, 2021