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The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated injections directly into the tumor tissue) or intravenously (as repeated doses directly into a vein) in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADC-1013 intratumoral | Experimental | ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intratumoral injection every second week for 8 weeks. Patients that do not progress will be offered continued treatment until complete response, confirmed progressive disease, or clinical deterioration. |
|
| ADC-1013 intravenous | Experimental | ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intravenous infusion every second week until complete response, confirmed progressive disease, or clinical deterioration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADC-1013 | Biological | Agonistic human monoclonal IgG1 anti-CD40 antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of increasing doses of ADC-1013, assessed by medical review of AE reports and vital signs measurements (blood pressure, pulse rate, body temperature), physical examinations, ECGs and clinical laboratory tests. | Dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended Phase 2 dose of ADC-1013 administered intratumorally or intravenously will be defined. | From start of study until end of study (appr 28 days after last dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of ADC-1013 after single and repeated administrations assessed by the following parameters: Cmax, Tmax, elimination half-life, AUC0-∞, total serum clearance (CL) and the volume of distribution at steady state (Vss). | From first dose until 55 days after first dose | |
| Immunogenicity of ADC-1013 after repeated administrations assessed by anti-drug antibody (ADA) titers in serum |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Norlén, MD, PhD | Alligator Biosciene AB, Sweden | Study Director |
| Dorte Nielsen, MD, PhD | Department of Oncology Herlev Hospital, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Cancer Research, Department of Oncology, Herlev Hospital | Herlev | Herlev | DK-2730 | Denmark | ||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000602878 | mitazalimab |
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| From first dose until end of study (appr 28 days after last dose) |
| Clinical efficacy (i.e. anti-tumor activity) of ADC-1013 assessed by immune-related RECIST (irRECIST) and RECIST 1.1. | From start of study until end of study (appr 28 days after last dose) |
| Kliniska prövningsenheten (KPE), Karolinska University Hospital |
| Solna |
| Stockholm County |
| SE-171 76 |
| Sweden |
| Department of Oncology, Uppsala University Hospital | Uppsala | Uppsala County | SE-751 85 | Sweden |
| Department of Oncology, Queen Elisabeth Hospital | Edgbaston | Birmingham | B15 2TH | United Kingdom |
| The Clatterbridge Cancer Centre | Bebington | Wirral | CH63 4JY | United Kingdom |