Solid Tumor, AdultPhase 1/2EVICTIONNCT04243499
First-in-Human Study of ICT01 in Patients With Advanced Cancer
A Phase 1/2 study testing IV ICT01 in people with Solid Tumor, Adult and Hematopoietic/Lymphoid Cancer, run by ImCheck Therapeutics, an Ipsen company at 29 sites in 6 countries.
Trial summary
Part 1 will be a dose escalation study of IV ICT01 (a monoclonal antibody targeting BTN3A) as monotherapy in patients with advanced solid or hematologic tumors, followed by a cohort examining the combination of ICT01 plus pembrolizumab (Keytruda). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Hematopoietic/Lymphoid Cancer
- What is being tested?
- IV ICT01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 29 sitesin 6 countries
- Study dates
- 5 Mar 2020to 15 Oct 2027
- Phase
- Phase 1/2
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
- Voluntarily signed informed consent form.
- Relapsed/refractory patients with histologically or cytologically confirmed diagnosis of advanced-stage or recurrent cancer, including:
- Group A: bladder, breast, colon, gastric, melanoma, ovarian, prostate and PDAC Group B: hematologic malignancies including acute myeloid leukemia, acute lymphocytic leukemia, Diffuse large B cell lymphoma and follicular lymphoma Group C: melanoma, cervical, bladder, gastric, head and neck SCC, and lymphoma (according to the approved package labeling of the ICI) Part 2, Group D: Ovarian cancer (2L/3L) with baseline g9d2 T cells > 20K Part 2, Group E: metastatic castrate resistant prostate cancer (2L/3L) with baseline g9d2 T cells > 20K Part 2, Group F: newly diagnosed AML starting venetoclax/azacitidine Part 2, Group G: checkpoint-refractory metastatic melanoma with g9d2 T cells >5K Part 2, Group H: chemotx-refractory or Pt-ineligible urotherlial cancer (bladder) with g9d2 T cells >5K Part 2, Group I: checkpoint-refractory, metastatic HNSCC with g9d2 T cells >5K
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Life expectancy > 3 months as assessed by the Investigator
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts
Who cannot join
- Any malignancy of Vγ9Vδ2 T cell origin
- Any anti-tumor-directed drug therapy within 28 days or 5 times the elimination half-life (whichever is shorter) before study treatment (does not apply to patients receiving ICI for the combination arm)
- Treatment with investigational drug(s) 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 need for ongoing treatment.
- 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) and/or AEs ≥grade 2 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with replacement hormone therapy.
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- Within 4 weeks of major surgery
- Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
- Primary or secondary immune deficiency
- Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
France12 sites
Institut Bergonie
Bordeaux, 33000
Haut Leveque
Bordeaux, 33600
Centre Hospitalier Lyon Sud
Lyon, 69310
Centre Lyon Berard
Lyon
CHU Lyon
Lyon
Institut Paoli-Calmettes
Marseille
CHU Nantes
Nantes, 44093
Centre Antoine Lacassagne
Nice, 06189
Pitie-Salpetriere
Paris, 75013
Institut Curie
Paris, 75248
Gustave Roussy
Paris
CHU Poitiers
Poitiers, 86000
United States8 sites
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
US Oncology Research
Irving, Texas, 75063
Yale Cancer Center
New Haven, Connecticut, 06511
University of Washington
Seattle, Washington, 98133
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Montefiore Medical Center
The Bronx, New York, 10467
Spain4 sites
START Barcelone HM Nou Delfos
Barcelona, 08023
Vall d'Hebron Instiute of Oncology
Barcelona
START Madrid-FJD, Hospital Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario HM Sanchinarro
Madrid, 28050
Germany2 sites
University Carl Gustav Carus Clinical Trial Unit
Dresden
universitatklinikum Wurburg
Würzburg
United Kingdom2 sites
NHS Greater Glasgow and Clyde, Beatson West of Scotland Cancer Centre
Glasgow
Institute of Cancer Research
London
About this study
Official title: A First-in-human, Two-part Clinical Study to Assess the Safety, Tolerability and Activity of IV Doses of ICT01 as Monotherapy and in Combination With a Checkpoint Inhibitor, in Patients With Advanced-stage, Relapsed/Refractory Cancer
Part 1 will be a dose escalation study of IV ICT01 (a monoclonal antibody targeting BTN3A) as monotherapy in patients with advanced solid or hematologic tumors, followed by a cohort examining the combination of ICT01 plus pembrolizumab (Keytruda). Part 2 will be a cohort expansion into 2 solid tumor indications and one hematologic malignancy for ICT01 monotherapy, and 3 solid tumor indications for the combination of ICT01 plus pembrolizumab.
- Conditions
- Solid Tumor, Adult, Hematopoietic/Lymphoid Cancer
- Being tested
- IV ICT01
- Keywords
- gamma delta T cells, butyrophilin, pembrolizumab
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV ICT01Biological
humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| IV ICT01 Monotherapy | Experimental | Up to six ICT01 dose levels administered as IV monotherapy every 3 weeks will be tested in Part 1 Dose Escalation and up to 2 dose levels in Part 2 Cohort Expansion Receives: Biological: IV ICT01 |
| IV ICT01 + IV Pembrolizumab | Experimental | A range of IV ICT01 doses administered every 3 weeks will be tested in combination with 200 mg pembrolizumab in Part 1 Dose Escalation and up to 2 dose levels of ICT01 plus 200 mg pembrolizumab in Part 2 Cohort Expansion Receives: Biological: IV ICT01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with TEAES (Part 1)
Treatment emergent adverse events (TEAEs) with severity according to National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0.
Measured: From baseline to at least 6 months
Percentage of participants with TEAES leading to discontinuation of study treatment or treatment modifications (Part 1)
Treatment emergent adverse events (TEAEs) with severity according to National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0.
Measured: From baseline to at least 6 months
Percentage of participants with SAEs (Part 1)
Serious Adverse Events (SAEs) with severity according to National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0
Measured: From baseline to at least 6 months
Percentage of participants with clinically significant change from baseline clinical laboratory abnormalities (Part 1)
With severity measured according to NCI-CTCAE Version 5.0
Measured: From baseline to at least 6 months
Percentage of participants with clinically significant change from baseline vital sign readings (Part 1)
Vital signs will be assessed by the investigators for clinical significance.
Measured: From baseline to at least 6 months
Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings (Part 1)
12-lead (echocardiogram) ECGs will be assessed by the investigators for clinical significance.
Measured: From baseline to at least 6 months
Percentage of participants with clinically significant change from baseline physical examinations (Part 1)
Physical examinations will be assessed by the investigators for clinical significance.
Measured: From baseline to at least 6 months
Duration of Complete Response (DCR) (Part 2)
DCR according to RECIST Version 1.1 for all groups except Group F (complete response [CR] + partial response [PR] + stable disease [SD]);
Measured: From baseline to at least 6 months
Secondary outcomes (6)
Change from Baseline in the Number of Circulating Gamma Delta T Cells
Flow cytometric counting of circulating gamma delta T cells
Measured: 28 days
Cmax following the first dose of ICT01
PK parameter from serum ICT01 levels
Measured: 1 day
AUC following the first dose of ICT01
PK parameter from serum ICT01 levels
Measured: 21 days
Clearance at steady-state of ICT01
PK parameter from serum ICT01 levels
Measured: 6 months
Half-life of ICT01
PK parameter from serum ICT01 levels
Measured: 6 months
Objective Response Rate using RECIST for solid tumor patients (Part 2)
RECIST is measured every 8 weeks during treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start5 Mar 2020
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to a dose level of ICT01 at the time of their enrollment
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImCheck Therapeutics, an Ipsen company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243499
- Sponsor's protocol ID
- ICT01-101
- Other IDs
- 2024-515560-30-00
- Acronym
- EVICTION
- Status last verified
- Sep 2026
- First submitted
- 24 Jan 2020
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No