First-in-Human Study of ICT01 in Patients With Advanced Cancer
NCT ID: NCT04243499
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
292 participants
INTERVENTIONAL
2020-03-05
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IV ICT01 Monotherapy
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
IV ICT01
humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody
IV ICT01 + IV Pembrolizumab
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
IV ICT01
humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody
Interventions
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IV ICT01
humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody
Eligibility Criteria
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Inclusion Criteria
2. 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
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 Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or \>5% marrow blasts
Exclusion Criteria
2. 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)
3. Treatment with investigational drug(s) 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 need for ongoing treatment.
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) 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.
7. Within 4 weeks of major surgery
8. Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
9. Primary or secondary immune deficiency
10. Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
18 Years
ALL
No
Sponsors
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ImCheck Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Katrien Lemmens, MD, PhD
Role: STUDY_DIRECTOR
ImCheck Therapeutics
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Montefiore Medical Center
The Bronx, New York, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
US Oncology Research
Irving, Texas, United States
University of Washington
Seattle, Washington, United States
Institut Jules Bordet
Brussels, , Belgium
Institut Bergonie
Bordeaux, , France
Haut Leveque
Bordeaux, , France
Centre Hospitalier Lyon Sud
Lyon, , France
Centre Lyon Berard
Lyon, , France
CHU Lyon
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
CHU Nantes
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Pitie-Salpetriere
Paris, , France
Institut Curie
Paris, , France
Gustave Roussy
Paris, , France
CHU Poitiers
Poitiers, , France
University Carl Gustav Carus Clinical Trial Unit
Dresden, , Germany
universitatklinikum Wurburg
Würzburg, , Germany
START Barcelone HM Nou Delfos
Barcelona, , Spain
Vall d'Hebron Instiute of Oncology
Barcelona, , Spain
START Madrid-FJD, Hospital Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
NHS Greater Glasgow and Clyde, Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Institute of Cancer Research
London, , United Kingdom
Countries
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Other Identifiers
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ICT01-101
Identifier Type: -
Identifier Source: org_study_id