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ADC-1013 First-in-Human Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02379741
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neoplasms Solid Tumors Biological: ADC-1013 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2015
Actual Primary Completion Date : March 8, 2017
Actual Study Completion Date : March 8, 2017

Arm Intervention/treatment
Experimental: ADC-1013 intratumoral
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.
Biological: ADC-1013
Agonistic human monoclonal IgG1 anti-CD40 antibody

Experimental: ADC-1013 intravenous
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.
Biological: ADC-1013
Agonistic human monoclonal IgG1 anti-CD40 antibody




Primary Outcome Measures :
  1. 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. [ Time Frame: 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 :
  1. 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). [ Time Frame: From first dose until 55 days after first dose ]
  2. Immunogenicity of ADC-1013 after repeated administrations assessed by anti-drug antibody (ADA) titers in serum [ Time Frame: From first dose until end of study (appr 28 days after last dose) ]
  3. Clinical efficacy (i.e. anti-tumor activity) of ADC-1013 assessed by immune-related RECIST (irRECIST) and RECIST 1.1. [ Time Frame: From start of study until end of study (appr 28 days after last dose) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379741


Locations
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Denmark
Center for Cancer Research, Department of Oncology, Herlev Hospital
Herlev, Denmark, DK-2730
Sweden
Kliniska prövningsenheten (KPE), Karolinska University Hospital
Solna, Stockholm, Sweden, SE-171 76
Department of Oncology, Uppsala University Hospital
Uppsala, Sweden, SE-751 85
United Kingdom
Department of Oncology, Queen Elisabeth Hospital
Edgbaston, Birmingham, United Kingdom, B15 2TH
The Clatterbridge Cancer Centre
Bebington, Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Alligator Bioscience AB
Investigators
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Study Director: Per Norlén, MD, PhD Alligator Biosciene AB, Sweden
Study Chair: Dorte Nielsen, MD, PhD Department of Oncology Herlev Hospital, Denmark
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Responsible Party: Alligator Bioscience AB
ClinicalTrials.gov Identifier: NCT02379741    
Other Study ID Numbers: A-14-1013-C-01
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Keywords provided by Alligator Bioscience AB:
Antibodies
Antibodies, Monoclonal
Antineoplastic agent
Physiological effects of drugs
Therapeutic uses
Clinical Trial, Phase I
Immunotherapy, Active
CD40 Antigen
Immunologic Factors
Injections, Intralesional