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

Sponsor: ImCheck Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04243499

Provider View

This clinical trial is testing a new drug, ICT01, alone and in combination with pembrolizumab (Keytruda) to see if it is safe and effective for treating advanced cancers. The study will first determine the best dose and then expand to include more patients with specific types of cancer.

Patient Parameters

Program Overview

The study is divided into two parts. Part 1 will test different doses of ICT01, a new monoclonal antibody, to find the safest and most effective dose for patients with advanced solid or blood cancers. After that, the study will explore how well ICT01 works when combined with pembrolizumab (Keytruda). Part 2 will expand to include more patients with specific types of solid tumors and blood cancers to further evaluate the effectiveness of ICT01 alone and in combination with pembrolizumab.

Eligibility Criteria

Inclusion Criteria

  • Must voluntarily agree to participate and sign a consent form.
  • Have advanced or recurrent cancer that has been confirmed by lab tests, including:
    • Group A: Bladder, breast, colon, stomach, melanoma, ovarian, prostate, and pancreatic cancer.
    • Group B: Blood cancers like acute myeloid leukemia, acute lymphocytic leukemia, and certain types of lymphoma.
    • Group C: Melanoma, cervical, bladder, stomach, head and neck cancer, and lymphoma.
    • Part 2, Group D: Ovarian cancer with specific immune cell levels.
    • Part 2, Group E: Advanced prostate cancer with specific immune cell levels.
    • Part 2, Group F: Newly diagnosed acute myeloid leukemia starting specific treatments.
    • Part 2, Group G: Advanced melanoma resistant to certain treatments with specific immune cell levels.
    • Part 2, Group H: Bladder cancer not responding to chemotherapy or not eligible for platinum treatment with specific immune cell levels.
    • Part 2, Group I: Advanced head and neck cancer resistant to certain treatments with specific immune cell levels.
  • Be in good overall health with a performance status score of 0 or 1.
  • Have a life expectancy of more than 3 months.
  • Have at least one measurable tumor or specific level of cancer cells in the bone marrow.

Exclusion Criteria

  • Have a cancer originating from specific immune cells (Vγ9Vδ2 T cells).
  • Have received any cancer treatment within 28 days before the study, except for those on pembrolizumab for the combination part of the study.
  • Have taken any experimental drugs within 28 days before the study.
  • Are on high doses of steroids for the last 28 days and need to continue.
  • Have rapidly progressing cancer with a risk of life-threatening complications.
  • Have ongoing side effects from previous treatments that are not resolved, except for certain stable conditions.
  • Have had major surgery within the last 4 weeks.
  • Have a history of active autoimmune disorders needing treatment in the last year.
  • Have a primary or secondary immune deficiency.
  • Have active and uncontrolled infections needing intravenous treatment.

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