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Phase I

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

  • Study HIC#:2000029250
  • Last Updated:07/12/2021

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.

  • Start Date02/22/2021
  • End Date12/01/2022

Trial Purpose and Description

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

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

Sub-Investigators

For more information about this study, contact: