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Brief Title: ADC-1013 First-in-Human Study
Official Title: A First-in-human, Multicenter, Open-label, Multiple Ascending Dose Phase I Study in Patients With Advanced Solid Tumors to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intratumorally or Intravenously Administered ADC-1013
Study ID: NCT02379741
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Per Norlén, MD, PhD
Affiliation: Alligator Biosciene AB, Sweden
Role: STUDY_DIRECTOR
Name: Dorte Nielsen, MD, PhD
Affiliation: Department of Oncology Herlev Hospital, Denmark
Role: STUDY_CHAIR