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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV ICT01 | Biological | humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (Parts 1 & 2) | Incidence of treatment-emergent adverse events | 12 months |
| Disease Control Rate using RECIST for solid tumor patients (Part 2) | RECIST is measured every 8 weeks during treatment | 12 months |
| Disease Control Rate using RECIL for lymphoma patients (Part 2) | RECIL is measured every 8 weeks during treatment | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Number of Circulating Gamma Delta T Cells | Flow cytometric counting of circulating gamma delta T cells | 28 days |
| Change from Baseline in the Activation State of Circulating Gamma Delta T Cells |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrien Lemmens, MD, PhD | ImCheck Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| City of Hope Comprehensive Cancer Center |
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Patients will be assigned to a dose level of ICT01 at the time of their enrollment
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Flow cytometric measurement of CD69 and Ki67 expression on gamma delta T cells
| 28 days |
| Cmax following the first dose of ICT01 | PK parameter from serum ICT01 levels | 1 day |
| AUC following the first dose of ICT01 | PK parameter from serum ICT01 levels | 21 days |
| Clearance at steady-state of ICT01 | PK parameter from serum ICT01 levels | 6 months |
| Half-life of ICT01 | PK parameter from serum ICT01 levels | 6 months |
| Objective Response Rate using RECIST for solid tumor patients (Part 2) | RECIST is measured every 8 weeks during treatment | 12 months |
| Duarte |
| California |
| 91010 |
| United States |
| Yale Cancer Center | New Haven | Connecticut | 06511 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| US Oncology Research | Irving | Texas | 75063 | United States |
| University of Washington | Seattle | Washington | 98133 | United States |
| Institut Jules Bordet | Brussels | Belgium |
| Institut Bergonie | Bordeaux | 33000 | France |
| Haut Leveque | Bordeaux | 33600 | France |
| Centre Hospitalier Lyon Sud | Lyon | 69310 | France |
| Centre Lyon Berard | Lyon | France |
| CHU Lyon | Lyon | France |
| Institut Paoli-Calmettes | Marseille | France |
| CHU Nantes | Nantes | 44093 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Pitie-Salpetriere | Paris | 75013 | France |
| Institut Curie | Paris | 75248 | France |
| Gustave Roussy | Paris | France |
| CHU Poitiers | Poitiers | 86000 | France |
| University Carl Gustav Carus Clinical Trial Unit | Dresden | Germany |
| universitatklinikum Wurburg | Würzburg | Germany |
| START Barcelone HM Nou Delfos | Barcelona | 08023 | Spain |
| Vall d'Hebron Instiute of Oncology | Barcelona | Spain |
| START Madrid-FJD, Hospital Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| NHS Greater Glasgow and Clyde, Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom |
| Institute of Cancer Research | London | United Kingdom |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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