NCT04243499

First-in-Human Study of ICT01 in Patients With Advanced Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: ImCheck Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Solid Tumor, Adult
• Hematopoietic/Lymphoid Cancer

Interventions

Type	Name	Description
BIOLOGICAL	IV ICT01	humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody

Timeline

• Start date: 2020-03-05
• Primary completion: 2025-10-15
• Completion: 2026-10-01
• First posted: 2020-01-28
• Last updated: 2026-01-27

Locations

29 sites across 6 countries: United States, Belgium, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study