Clinical trial NCT02379741: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Solid Tumors
Keywords: Antibodies
Antibodies, Monoclonal
Antineoplastic agent
Physiological effects of drugs
Therapeutic uses
Clinical Trial, Phase I
Immunotherapy, Active
CD40 Antigen
Immunologic Factors
Injections, Intralesional
Lead sponsor: Alligator Bioscience AB
Sponsor class: INDUSTRY
First posted: 2015-03-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Major Inclusion Criteria:

* Diagnosis of advanced solid tumor disease
* Performance status of 0-1 on the ECOG scale
* Life expectancy of at least 3 months

Major Exclusion Criteria:

* Organ transplant recipient
* Autoimmune disorder
* Other malignancy (except localized prostate cancer, adequately treated basal skin cancer or carcinoma in-situ of the cervix)

Primary outcomes:
measure: 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.
timeFrame: From start of study until end of study (appr 28 days after last dose)
Secondary outcomes:
measure: 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).
timeFrame: From first dose until 55 days after first dose
measure: Immunogenicity of ADC-1013 after repeated administrations assessed by anti-drug antibody (ADA) titers in serum
timeFrame: From first dose until end of study (appr 28 days after last dose)
measure: Clinical efficacy (i.e. anti-tumor activity) of ADC-1013 assessed by immune-related RECIST (irRECIST) and RECIST 1.1.
timeFrame: From start of study until end of study (appr 28 days after last dose)
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Center for Cancer Research, Department of Oncology, Herlev Hospital
city: Solna
country: Sweden
facility: Kliniska prövningsenheten (KPE), Karolinska University Hospital
state: Stockholm
city: Uppsala
country: Sweden
facility: Department of Oncology, Uppsala University Hospital
city: Edgbaston
country: United Kingdom
facility: Department of Oncology, Queen Elisabeth Hospital
state: Birmingham
city: Bebington
country: United Kingdom
facility: The Clatterbridge Cancer Centre
state: Wirral
Study officials:
affiliation: Alligator Biosciene AB, Sweden
name: Per Norlén, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Oncology Herlev Hospital, Denmark
name: Dorte Nielsen, MD, PhD
role: STUDY_CHAIR
References: