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

December 17, 2025 updated by: ImCheck Therapeutics

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Institute Gustave Roussy
      • Toulouse, France
        • IUCT Oncopole Claudius Regaud
  • Germany
      • Dresden, Germany
        • University Carl Gustav Carus
      • Würzburg, Germany
        • Universitätsklinikum Wuerzburg
  • United Kingdom
      • Sutton, United Kingdom
        • The Institute of Cancer Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Relapsed/refractory patients who have failed at least 2 lines of systemic therapy or who failed first line therapy and are intolerant of or have a contraindication to the standard second line of therapy with histologically or cytologically confirmed diagnosis of:

    1. metastatic colorectal cancer (CRC):
    2. metastatic ovarian cancer:
    3. metastatic castration-resistant prostate cancer (mCRPC)
    4. metastatic pancreatic ductal adenocarcinoma (PDAC)

    5. metastatic or unresectable refractory melanoma

      2) Availability of baseline tumor biopsy and willingness to undergo on-study tumor biopsies 3) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 4) Life expectancy > 3 months as assessed by the Investigator 5) At least 1 measurable lesion per RECIST1.1

      Exclusion Criteria:

      1. Any malignancy of γ9δ2 T cell origin
      2. Any systemic anti-tumor-directed drug therapy within 28 days or 5 times the elimination half-life (whichever is shorter) before study treatment
      3. Treatment with investigational drugs within 28 days before study treatment
      4. Systemic steroids at a daily dose of > 10 mg of prednisone, > 2 mg of dexamethasone or equivalent, for the last 28 days and ongoing
      5. Patients with rapidly progressing disease defined as advanced/metastatic, symptomatic, visceral spread, with a risk of life-threatening complications in the short term (e.g., during Screening Period/ treatment washout) that includes patients with massive uncontrolled effusions pleural, pericardial, peritoneal, pulmonary lymphangitis, and over 50% liver involvement
      6. Ongoing immune-related adverse events (irAEs) ≥grade 2 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy.
      7. Ongoing systemic autoimmune disease requiring systemic immunosuppressive therapy
      8. Primary or secondary immune deficiency
      9. Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
      10. Patients with contraindication to IL-2 treatment according to the SmPC/package insert

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose level 2 ICT01 + Low dose SC IL-2
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.
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
Other Names:
  • IL-2
Experimental: Dose Level 1 ICT01 + High dose SC IL-2
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.
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
Other Names:
  • IL-2
Experimental: Dose level 3 ICT01 + Low dose SC IL-2
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.
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
Other Names:
  • IL-2
Experimental: Dose level 4 ICT01 + Low dose SC IL-2
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.
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
Other Names:
  • IL-2
Experimental: Dose level 1 ICT01 + Low dose SC IL-2
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.
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
Other Names:
  • IL-2
Experimental: Dose level 5 ICT01 + Low dose SC IL-2
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.
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
Other Names:
  • IL-2
Experimental: Primer Dose level 2 ICT01+ Low dose SC IL-2 + Booster Dose level 2 ICT01
ICT01 IV is given on Day 1 of every 21-day cycle and on day 8 of Cycles 1-3. SC IL-2 is administered on Days 1-5 of Cycles 1/2/3 only.
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
Other Names:
  • IL-2
Experimental: Primer Dose level 2 ICT01+ Low dose SC IL-2 + Booster Dose level 3 ICT01
ICT01 IV is given on Day 1 of every 21-day cycle and on day 8 of Cycles 1-3. SC IL-2 is administered on Days 1-5 of Cycles 1/2/3 only.
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
Other Names:
  • IL-2
Experimental: Dose level 2 ICT01 + Low dose SC IL-2 + Pembrolizumab
ICT01 IV and Pembrolizumab are given on Day 1 of every 21-day cycle. SC IL-2 is administred Days 1-5 of cycles 1/2/3 only.
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
Other Names:
  • IL-2
Drug: Pembrolizumab injection
200mg administered following ICT01 + LDSC IL-2 over 30 min Q3W
Experimental: Dose level 4 ICT01 + Low dose SC IL-2 + Pembrolizumab
ICT01 IV and Pembrolizumab are given on Day 1 of every 21-day cycle. SC IL-2 is administred Days 1-5 of cycles 1/2/3 only.
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
Other Names:
  • IL-2
Drug: Pembrolizumab injection
200mg administered following ICT01 + LDSC IL-2 over 30 min Q3W
Experimental: Primer Dose level 2 ICT01+ Low dose SC IL-2 + Pembrolizumab + Booster Dose level 2 ICT01
ICT01 IV and Pembrolizumab are given on Day 1 of every 21-day cycle. ICT01 IV is given on day 8 of Cycles 1-3. SC IL-2 is administered on Days 1-5 of Cycles 1/2/3 only.
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
Other Names:
  • IL-2
Drug: Pembrolizumab injection
200mg administered following ICT01 + LDSC IL-2 over 30 min Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-Emergent Adverse Events
Time Frame: 1 year
Incidence and severity of adverse events related to study treatment
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the number of circulating g9d2 T cells
Time Frame: Cycle Days 8 & 15 for the first 3 cycles
flow cytometry measurement of circulating and intratumoral g9d2 T cells
Cycle Days 8 & 15 for the first 3 cycles
Disease Control Rate
Time Frame: 1 year
Stable disease or better by RECIST1.1
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImCheck Therapeutics

Collaborators

ILife Consulting
Exystat

Investigators

  • Study Director: Katrien Lemmens, MD, PhD, ImCheck Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2022

Primary Completion (Actual)

October 9, 2025

Study Completion (Actual)

October 9, 2025

Study Registration Dates

First Submitted

March 24, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICT01-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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