🏛️ Verified NIH Record • Updated 2026-08-10

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

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: ImCheck Therapeutics, an Ipsen company

🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (11 items).

Location: Banner MD Anderson Cancer Center — Gilbert, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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
  • 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
  • Primary or secondary immune deficiency
  • Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗