Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Analgesics

Pembrolizumab

Aldesleukin

Interleukin-2

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

The best regimen of ICT01+IL-2 will be combined with pembrolizumab at the approved dose since the combination of ICT01+IL-2 induces upregulation of PD-1 on g9d2 T cells and in the TME.

For all arms, ICT01 IV is given on Day 1 of every 21-day cycle. SC IL-2 is administered Days 1-5 of cycles 1/2/3 only.

ICT01

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

Proleukin Injectable Product

200mg administered following ICT01 + LDSC IL-2 over 30 min Q3W

Pembrolizumab injection

Paul Frohna, MD, PhD

Stephane Champiat, MD, PhD

Paul FROHNA, MD, PhD

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.

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

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors	NCT05307874	Solid Tumor, Ad...	ICT01 Proleukin Injec... Pembrolizumab i...	18 Years -	ImCheck Therapeutics
Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors	NCT05307874	Solid Tumor, Ad...	ICT01 Proleukin Injec... Pembrolizumab i...	18 Years -	ImCheck Therapeutics

Spots Global Cancer Trial Database for proleukin injectable product