Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
First-in-Human Study of ICT01 in Patients With Advanced Cancer
NCT04243499 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL IV ICT01
Study Locations (20)
Other
- Institut Jules Bordet — Brussels
- Institut Bergonie — Bordeaux
- Haut Leveque — Bordeaux
- Centre Hospitalier Lyon Sud — Lyon
- Centre Lyon Berard — Lyon
- CHU Lyon — Lyon
- Institut Paoli-Calmettes — Marseille
- CHU Nantes — Nantes
- Centre Antoine Lacassagne — Nice
- Pitie-Salpetriere — Paris
- Institut Curie — Paris
- Gustave Roussy — Paris
Texas
- The University of Texas MD Anderson Cancer Center — Houston
- US Oncology Research — Irving
Arizona
- Banner MD Anderson Cancer Center — Gilbert
California
- City of Hope Comprehensive Cancer Center — Duarte
Connecticut
- Yale Cancer Center — New Haven
Florida
- H. Lee Moffitt Cancer Center and Research Institute — Tampa
New York
- Montefiore Medical Center — The Bronx
Washington
- University of Washington — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2020-03-05 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04243499
The ClinicalTrials.gov registry entry for NCT04243499 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 292 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ImCheck Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Solid Tumor, Adult appearing as the primary indexed condition, and to 1 intervention — of which IV ICT01 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04243499 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Texas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04243499 about?
NCT04243499 is a clinical study titled "First-in-Human Study of ICT01 in Patients With Advanced Cancer". 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...
What is the current status of trial NCT04243499?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 292 participants. The study started on 2020-03-05. Estimated completion is 2026-10.
What conditions does trial NCT04243499 study?
This clinical trial studies the following conditions: Solid Tumor, Adult, Hematopoietic/Lymphoid Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04243499?
The interventions under investigation include: IV ICT01 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04243499?
This trial is sponsored by ImCheck Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04243499 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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