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

NCT05307874 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-12-24

No results posted yet for this study

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.

Conditions

  • Solid Tumor, Adult

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

Sponsors & Collaborators

  • ILife Consulting

    collaborator UNKNOWN

  • Exystat

    collaborator OTHER

  • ImCheck Therapeutics

    lead INDUSTRY

Principal Investigators

  • Katrien Lemmens, MD, PhD · ImCheck Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-04
Primary Completion
2025-10-09
Completion
2025-10-09

Countries

  • France
  • Germany
  • United Kingdom

Study Locations

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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 NCT05307874 on ClinicalTrials.gov