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Solid Tumor, AdultPhase 1/2EVICTION-2NCT05307874

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

A Phase 1/2 study testing ICT01, Proleukin Injectable Product and Pembrolizumab injection in people with Solid Tumor, Adult, run by ImCheck Therapeutics, an Ipsen company at 5 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Adult
What is being tested?
ICT01, Proleukin Injectable Product and Pembrolizumab injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
5 sitesin 3 countries
Study dates
4 May 2022to 9 Oct 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • metastatic colorectal cancer (CRC):
  • metastatic ovarian cancer:
  • metastatic castration-resistant prostate cancer (mCRPC)
  • metastatic pancreatic ductal adenocarcinoma (PDAC)
  • 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

Who cannot join

  • Any malignancy of γ9δ2 T cell origin
  • Any systemic anti-tumor-directed drug therapy within 28 days or 5 times the elimination half-life (whichever is shorter) before study treatment
  • Treatment with investigational drugs within 28 days before study treatment
  • Systemic steroids at a daily dose of > 10 mg of prednisone, > 2 mg of dexamethasone or equivalent, for the last 28 days and ongoing
  • 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
  • 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.
Show all 10Show fewer
  • Ongoing systemic autoimmune disease requiring systemic immunosuppressive therapy
  • Primary or secondary immune deficiency
  • Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
  • Patients with contraindication to IL-2 treatment according to the SmPC/package insert

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

France2 sites

  • Institute Gustave Roussy

    Paris

  • IUCT Oncopole Claudius Regaud

    Toulouse

Other trials in France

Germany2 sites

  • University Carl Gustav Carus

    Dresden

  • Universitätsklinikum Wuerzburg

    Würzburg

Other trials in Germany

United Kingdom1 site

  • The Institute of Cancer Research

    Sutton

Other trials in United Kingdom

About this study

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)

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.

Being tested
ICT01, Proleukin Injectable Product, Pembrolizumab injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICT01Drug

    anti-BTN3A mAb IV Q3W

  • Proleukin Injectable ProductDrug

    Also called IL-2

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

  • Pembrolizumab injectionDrug

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

Study groups in NCT05307874
Study groupRoleWhat they receive
Dose level 2 ICT01 + Low dose SC IL-2ExperimentalFor 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.
Receives: Drug: ICT01; Drug: Proleukin Injectable Product
Dose Level 1 ICT01 + High dose SC IL-2ExperimentalFor 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.
Receives: Drug: ICT01; Drug: Proleukin Injectable Product
Dose level 1 ICT01 + Low dose SC IL-2ExperimentalFor 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.
Receives: Drug: ICT01; Drug: Proleukin Injectable Product
Dose level 3 ICT01 + Low dose SC IL-2ExperimentalFor 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.
Receives: Drug: ICT01; Drug: Proleukin Injectable Product
Dose level 4 ICT01 + Low dose SC IL-2ExperimentalFor 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.
Receives: Drug: ICT01; Drug: Proleukin Injectable Product
Dose level 5 ICT01 + Low dose SC IL-2ExperimentalFor 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.
Receives: Drug: ICT01; Drug: Proleukin Injectable Product
Primer Dose level 2 ICT01+ Low dose SC IL-2 + Booster Dose level 2 ICT01ExperimentalICT01 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.
Receives: Drug: ICT01; Drug: Proleukin Injectable Product
Primer Dose level 2 ICT01+ Low dose SC IL-2 + Booster Dose level 3 ICT01ExperimentalICT01 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.
Receives: Drug: ICT01; Drug: Proleukin Injectable Product
Dose level 2 ICT01 + Low dose SC IL-2 + PembrolizumabExperimentalICT01 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.
Receives: Drug: ICT01; Drug: Proleukin Injectable Product; Drug: Pembrolizumab injection
Dose level 4 ICT01 + Low dose SC IL-2 + PembrolizumabExperimentalICT01 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.
Receives: Drug: ICT01; Drug: Proleukin Injectable Product; Drug: Pembrolizumab injection
Primer Dose level 2 ICT01+ Low dose SC IL-2 + Pembrolizumab + Booster Dose level 2 ICT01ExperimentalICT01 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.
Receives: Drug: ICT01; Drug: Proleukin Injectable Product; Drug: Pembrolizumab injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-Emergent Adverse Events

    Incidence and severity of adverse events related to study treatment

    Measured: 1 year

Secondary outcomes (2)

  1. Change from baseline in the number of circulating g9d2 T cells

    flow cytometry measurement of circulating and intratumoral g9d2 T cells

    Measured: Cycle Days 8 & 15 for the first 3 cycles

  2. Disease Control Rate

    Stable disease or better by RECIST1.1

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2022
  2. Study start4 May 2022
  3. Primary completion9 Oct 2025
  4. Study completion9 Oct 2025

Why it stopped: The study was terminated based on sponsor decision unrelated to safety or efficacy. The study met the key primary and secondary endpoints, however two patients were receiving treatment at the decision point, preventing protocol-defined completion.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05307874
Sponsor's protocol ID
ICT01-102
Acronym
EVICTION-2
Status last verified
Dec 2025
First submitted
24 Mar 2022
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • De Gassart A, Le KS, Brune P, Agaugue S, Sims J, Goubard A, Castellano R, Joalland N, Scotet E, Collette Y, Valentin E, Ghigo C, Pasero C, Colazet M, Guillen J, Cano CE, Marabelle A, De Bonno J, Hoet R, Truneh A, Olive D, Frohna P. Development of ICT01, a first-in-class, anti-BTN3A antibody for activating Vgamma9Vdelta2 T cell-mediated antitumor immune response. Sci Transl Med. 2021 Oct 20;13(616):eabj0835. doi: 10.1126/scitranslmed.abj0835. Epub 2021 Oct 20.

    PubMed 34669444

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ICT01, Proleukin Injectable Product and Pembrolizumab injection in people with Solid Tumor, Adult, run by ImCheck Therapeutics, an Ipsen company at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated based on sponsor decision unrelated to safety or efficacy. The study met the key primary and secondary endpoints, however two patients were receiving treatment at the decision point, preventing protocol-defined completion.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-Emergent Adverse Events (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05307874, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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