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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04243499
- Acronym / sponsor ID
- EVICTION / ICT01-101
- Conditions
- Solid Tumor, Adult, Hematopoietic/Lymphoid Cancer
- Keywords
- gamma delta T cells, butyrophilin, pembrolizumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 293 participants (actual)
- Lead sponsor
- ImCheck Therapeutics, an Ipsen companyIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be assigned to a dose level of ICT01 at the time of their enrollment
| Arm | Type | Receives |
|---|---|---|
| IV ICT01 Monotherapy | Experimental | Biological: IV ICT01Up 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 |
| IV ICT01 + IV Pembrolizumab | Experimental | Biological: IV ICT01A 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV ICT01humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody | Biological | IV ICT01 + IV Pembrolizumab, IV ICT01 Monotherapy |
Primary outcome
Percentage of participants with TEAES (Part 1)
Time frame: From baseline to at least 6 months
Treatment emergent adverse events (TEAEs) with severity according to National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0.
Percentage of participants with TEAES leading to discontinuation of study treatment or treatment modifications (Part 1)
Time frame: From baseline to at least 6 months
Treatment emergent adverse events (TEAEs) with severity according to National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0.
Percentage of participants with SAEs (Part 1)
Time frame: From baseline to at least 6 months
Serious Adverse Events (SAEs) with severity according to National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0
Percentage of participants with clinically significant change from baseline clinical laboratory abnormalities (Part 1)
Time frame: From baseline to at least 6 months
With severity measured according to NCI-CTCAE Version 5.0
Percentage of participants with clinically significant change from baseline vital sign readings (Part 1)
Time frame: From baseline to at least 6 months
Vital signs will be assessed by the investigators for clinical significance.
Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings (Part 1)
Time frame: From baseline to at least 6 months
12-lead (echocardiogram) ECGs will be assessed by the investigators for clinical significance.
Percentage of participants with clinically significant change from baseline physical examinations (Part 1)
Time frame: From baseline to at least 6 months
Physical examinations will be assessed by the investigators for clinical significance.
Duration of Complete Response (DCR) (Part 2)
Time frame: From baseline to at least 6 months
DCR according to RECIST Version 1.1 for all groups except Group F (complete response [CR] + partial response [PR] + stable disease [SD]);
6 secondary outcomes
Change from Baseline in the Number of Circulating Gamma Delta T Cells
Time frame: 28 days
Cmax following the first dose of ICT01
Time frame: 1 day
AUC following the first dose of ICT01
Time frame: 21 days
Clearance at steady-state of ICT01
Time frame: 6 months
Half-life of ICT01
Time frame: 6 months
Objective Response Rate using RECIST for solid tumor patients (Part 2)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
29 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France, United States, Spain, Germany, United Kingdom and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of participants with TEAES (Part 1) (time frame: From baseline to at least 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026.