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TERMINATED
NCT05307874
PHASE1/PHASE2

Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors

Sponsor: ImCheck Therapeutics, an Ipsen company

View on ClinicalTrials.gov

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

Interventions

DRUG

ICT01

anti-BTN3A mAb IV Q3W

DRUG

Proleukin Injectable Product

1 MIU/m2 SC IL-2 daily x 5 days for the first 3 cycles

DRUG

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