First-in-Human Study of ICT01 in Patients With Advanced Cancer (NCT04243499)
A First-in-human, Two-part Clinical Study to Assess the Safety, Tolerability and Activity of IV Doses of ICT01 as Monotherapy and in Combination With a Checkpoint Inhibitor, in Patients With Advanced-stage, Relapsed/Refractory Cancer
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Banner MD Anderson Cancer Center — Gilbert, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (29 Sites)
Showing the first 25 of 29 sites.
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- City of Hope Comprehensive Cancer Center — Duarte, California
- Yale Cancer Center — New Haven, Connecticut
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
- Montefiore Medical Center — The Bronx, New York
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- US Oncology Research — Irving, Texas
- University of Washington — Seattle, Washington
- 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,
- CHU Poitiers — Poitiers,
- University Carl Gustav Carus Clinical Trial Unit — Dresden,
- universitatklinikum Wurburg — Würzburg,
- START Barcelone HM Nou Delfos — Barcelona,
- Vall d'Hebron Instiute of Oncology — Barcelona,
📞 Contact the Study Coordinator
Phone: (877) 632-6789
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.