First-in-Human Study of ICT01 in Patients With Advanced Cancer (NCT04243499) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
First-in-Human Study of ICT01 in Patients With Advanced Cancer
United States, Belgium, France293 participantsStarted 2020-03-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily signed informed consent form.
. Relapsed/refractory patients with histologically or cytologically confirmed diagnosis of advanced-stage or recurrent cancer, including:
. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
. Life expectancy \> 3 months as assessed by the Investigator
. 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
. Any malignancy of Vγ9Vδ2 T cell origin
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since ICT01 is described as 'first-in-human,' meaning this is the earliest stage of human testing, what do you think is currently known — and not yet known — about its safety profile, and how does that uncertainty compare to my other treatment options?
2The trial is actively enrolling but no longer recruiting new participants — does that mean there's any realistic path for me to join, or should we focus our energy on other options right now?
3The first part of this study is primarily measuring how often patients experience serious side effects and treatment-related complications — based on what's been reported so far, what kinds of adverse events seem most relevant to my specific cancer type and overall health?
4This trial covers both solid tumors and blood cancers, which are very different — given my specific diagnosis, do you think the early data from this study is actually relevant to my situation, or is it mostly drawn from patients with a different cancer type than mine?
5Before considering a Phase 1/2 first-in-human trial like this, should I first explore whether standard approved treatments or more established clinical trials might be a better fit for where I am in my treatment journey?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants with TEAES (Part 1)
Timeframe: From baseline to at least 6 months
2
Percentage of participants with TEAES leading to discontinuation of study treatment or treatment modifications (Part 1)
Timeframe: From baseline to at least 6 months
3
Percentage of participants with SAEs (Part 1)
Timeframe: From baseline to at least 6 months
4
Percentage of participants with clinically significant change from baseline clinical laboratory abnormalities (Part 1)
Timeframe: From baseline to at least 6 months
5
Percentage of participants with clinically significant change from baseline vital sign readings (Part 1)
Timeframe: From baseline to at least 6 months
6
Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings (Part 1)
. 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)
. Treatment with investigational drug(s) within 28 days before study treatment
. 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.
. 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
. 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.
. Within 4 weeks of major surgery
. Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
Percentage of participants with clinically significant change from baseline physical examinations (Part 1)