ADC-1013 First-in-Human Study
- Conditions
- NeoplasmsSolid Tumors
- Registration Number
- NCT02379741
- Lead Sponsor
- Alligator Bioscience AB
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Diagnosis of advanced solid tumor disease
- Performance status of 0-1 on the ECOG scale
- Life expectancy of at least 3 months
Major
- Organ transplant recipient
- Autoimmune disorder
- Other malignancy (except localized prostate cancer, adequately treated basal skin cancer or carcinoma in-situ of the cervix)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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. From start of study until end of study (appr 28 days after last dose) Dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended Phase 2 dose of ADC-1013 administered intratumorally or intravenously will be defined.
- Secondary Outcome Measures
Name Time Method 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 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)
Trial Locations
- Locations (5)
Center for Cancer Research, Department of Oncology, Herlev Hospital
🇩🇰Herlev, Denmark
Kliniska prövningsenheten (KPE), Karolinska University Hospital
🇸🇪Solna, Stockholm, Sweden
Department of Oncology, Uppsala University Hospital
🇸🇪Uppsala, Sweden
Department of Oncology, Queen Elisabeth Hospital
🇬🇧Edgbaston, Birmingham, United Kingdom
The Clatterbridge Cancer Centre
🇬🇧Bebington, Wirral, United Kingdom
Center for Cancer Research, Department of Oncology, Herlev Hospital🇩🇰Herlev, Denmark