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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

Tracking Information
First Submitted Date  ICMJE February 16, 2015
First Posted Date  ICMJE March 5, 2015
Last Update Posted Date March 27, 2017
Study Start Date  ICMJE April 2015
Actual Primary Completion Date March 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
Safety and tolerability of increasing doses of intratumoral 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) and the maximum tolerated dose (MTD) of ADC-1013 will be defined.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
  • 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 ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
  • Pharmacokinetics of ADC-1013 after single and repeated intratumoral injections 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 ]
  • Immunogenicity of ADC-1013 after repeated intratumoral injections assessed by anti-drug antibody (ADA) titers in serum [ Time Frame: 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. [ Time Frame: From start of study until end of study (appr 28 days after last dose) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ADC-1013 First-in-Human Study
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasms
  • Solid Tumors
Intervention  ICMJE Biological: ADC-1013
Agonistic human monoclonal IgG1 anti-CD40 antibody
Study Arms  ICMJE
  • 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.
    Intervention: Biological: ADC-1013
  • 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.
    Intervention: Biological: ADC-1013
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2017)
24
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2015)
40
Actual Study Completion Date  ICMJE March 8, 2017
Actual Primary Completion Date March 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02379741
Other Study ID Numbers  ICMJE A-14-1013-C-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Alligator Bioscience AB
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alligator Bioscience AB
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Per Norlén, MD, PhD Alligator Biosciene AB, Sweden
Study Chair: Dorte Nielsen, MD, PhD Department of Oncology Herlev Hospital, Denmark
PRS Account Alligator Bioscience AB
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP