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NCT04243499 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Study of ICT01 in Patients With Advanced Cancer
A Phase 1 study of Solid Tumor, Adult and Hematopoietic/Lymphoid Cancer, sponsored by ImCheck Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 292
- Enrollment target
- 20
- Study locations
NCT04243499: Active Phase 1 study of Solid Tumor, Adult and Hematopoietic/Lymphoid Cancer, sponsored by ImCheck Therapeutics.
NCT04243499 is a Phase 1 study of Solid Tumor, Adult and Hematopoietic/Lymphoid Cancer that is active but no longer recruiting, run by ImCheck Therapeutics. The registered enrollment target is 292 participants, above the 186-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (57% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04243499, a Phase 1 study of Solid Tumor, Adult and Hematopoietic/Lymphoid Cancer, is active but no longer recruiting, sponsored by ImCheck Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 292 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Treatment emergent adverse events (TEAEs) with severity according to National Cancer Institute \[NCI\]- Common Terminology Criteria for Adverse Events \[CTCAE\] Version 5.0.
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 |
What the registry record for NCT04243499 still lists
NCT04243499 is an interventional study that assigns participants to a tested intervention. The registered 292 participants enrollment target is mid-sized for trials with a published cap, above the 186-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (57% higher).
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.
NCT04243499 names 20 study sites across 8 states, led by Other, Texas, Arizona.
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.
What interventions are being tested in trial NCT04243499?
The interventions under investigation include: IV ICT01 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04243499?
This trial is sponsored by ImCheck Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04243499's enrollment target sits among peer trials
292 16th of 72 higher than 57 of 72 other Solid Tumor, Adult trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor, Adult trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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