First-in-Human Study of ICT01 in Patients With Advanced Cancer

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Solid Tumor, Adult, Hematopoietic/Lymphoid Cancer

In brief

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.

Key facts

Study ID: NCT04243499
Run by: ImCheck Therapeutics, an Ipsen company
People needed: 293
Starts: 2020-03-05
Expected to finish: 2027-10-01
Last updated by the study team: 2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.
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

Where it is running

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

Full record on ClinicalTrials.gov

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