MedTrace Logo

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

NCT04243499 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2026-01-27

No results posted yet for this 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

  • Solid Tumor, Adult
  • Hematopoietic/Lymphoid Cancer

Interventions

BIOLOGICAL

IV ICT01

humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody

Sponsors & Collaborators

  • ImCheck Therapeutics

    lead INDUSTRY

Principal Investigators

  • Katrien Lemmens, MD, PhD · ImCheck Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-05
Primary Completion
2025-10-15
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04243499 on ClinicalTrials.gov