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 States292 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 range18 Years
SexALL
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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
✕. 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
What they're measuring
1
Adverse Events (Parts 1 & 2)
Timeframe: 12 months
2
Disease Control Rate using RECIST for solid tumor patients (Part 2)
Timeframe: 12 months
3
Disease Control Rate using RECIL for lymphoma patients (Part 2)