Clinical Research Directory
Browse clinical research sites, groups, and studies.
Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors
Sponsor: ImCheck Therapeutics, an Ipsen company
Summary
This is a phase I/IIa, two-part, open-label study to characterize the safety, tolerability, pharmacodynamics, and antitumor activity of ICT01 in combination with LDSC IL-2 in patients with advanced-stage solid tumors. Part 1 will be a dose escalation of IV ICT01 administered on the first day of every 21-day cycle (CnD1) to patients with advanced-stage solid tumors in combination with LDSC IL-2 (Proleukin®) administered daily on days 1-5 of cycles 1-3 (C1-3D1-5). Objectives of part 1 are to characterize the safety of the combination regimen and determine the RP2D for Part 2. Part 2 will comprise a maximum of 2 indications and 2 combination dosing regimens of ICT01 +LDSC IL-2, which will be supported by statistical power calculations once the indications are selected. The final regimen will be ICT01 + LDSC IL-2 + Pembrolizumab on a Q3W cycle. The primary objective of Part 2 is to demonstrate the efficacy of the combination regimen based on RECIST1.1 in one or more solid tumor indications.
Official title: A Two-part, Open-label, Clinical Study to Assess the Safety, Tolerability and Activity of Intravenous Doses of ICT01 in Combination With Low-dose Subcutaneous Interleukin-2 in Patients With Advanced Solid Tumors (EVICTION-2)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2022-05-04
Completion Date
2025-10-09
Last Updated
2026-07-30
Healthy Volunteers
No
Conditions
Interventions
ICT01
anti-BTN3A mAb IV Q3W
Proleukin Injectable Product
1 MIU/m2 SC IL-2 daily x 5 days for the first 3 cycles
Pembrolizumab injection
200mg administered following ICT01 + LDSC IL-2 over 30 min Q3W
Locations (5)
Institute Gustave Roussy
Paris, France
IUCT Oncopole Claudius Regaud
Toulouse, France
University Carl Gustav Carus
Dresden, Germany
Universitätsklinikum Wuerzburg
Würzburg, Germany
The Institute of Cancer Research
Sutton, United Kingdom