ICT01 for Advanced Cancers
(EVICTION Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop any anti-tumor drug therapy at least 28 days before starting the study treatment, unless you are receiving immune checkpoint inhibitors for the combination arm. If you are on systemic steroids above a certain dose, you must also stop them 28 days before the study.
What data supports the effectiveness of the drug ICT01 for advanced cancers?
Research shows that ICT01, an anti-BTN3A antibody, activates specific immune cells (Vγ9Vδ2 T cells) to target and kill cancer cells without harming healthy cells. In animal studies, ICT01 delayed tumor growth and improved survival, and early human trials suggest it is well tolerated and may enhance immune response in tumors.12345
Is ICT01 safe for humans?
What makes the drug ICT01 unique for treating advanced cancers?
ICT01 is unique because it activates a specific type of immune cell called Vγ9Vδ2 T cells to target and kill cancer cells without harming healthy cells, using a novel mechanism that does not rely on traditional tumor markers. This approach is different from many existing treatments that often target specific tumor antigens.12378
Research Team
Katrien Lemmens, MD, PhD
Principal Investigator
ImCheck Therapeutics
Eligibility Criteria
This trial is for adults with advanced-stage or recurrent cancers, including various solid tumors and blood cancers. Participants must have a certain level of immune cells (g9d2 T cells), an ECOG performance status ≤ 1, and a life expectancy over 3 months. They should not have rapidly progressing disease, active autoimmune disorders treated with immunosuppressants in the last year, primary/secondary immune deficiencies, uncontrolled infections requiring IV treatment, or recent anti-tumor therapies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Part 1 involves dose escalation of IV ICT01 as monotherapy and in combination with pembrolizumab
Cohort Expansion
Part 2 involves cohort expansion into specific tumor indications for ICT01 monotherapy and combination therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ICT01
Find a Clinic Near You
Who Is Running the Clinical Trial?
ImCheck Therapeutics
Lead Sponsor