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 ict01

Every month we try and update this database with for ict01 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ict01

Every month we try and update this database with for ict01 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ict01 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.