ADC-1013 First-in-Human Study

March 23, 2017 updated by: Alligator Bioscience AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, DK-2730
        • Center for Cancer Research, Department of Oncology, Herlev Hospital
  • Sweden
      • Uppsala, Sweden, SE-751 85
        • Department of Oncology, Uppsala University Hospital
    • Stockholm
      • Solna, Stockholm, Sweden, SE-171 76
        • Kliniska prövningsenheten (KPE), Karolinska University Hospital
  • United Kingdom
    • Birmingham
      • Edgbaston, Birmingham, United Kingdom, B15 2TH
        • Department of Oncology, Queen Elisabeth Hospital
    • Wirral
      • Bebington, Wirral, United Kingdom, CH63 4JY
        • The Clatterbridge Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From start of study until end of study (appr 28 days after last dose)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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)
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)
From start of study until end of study (appr 28 days after last dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alligator Bioscience AB

Investigators

  • Study Director: Per Norlén, MD, PhD, Alligator Biosciene AB, Sweden
  • Study Chair: Dorte Nielsen, MD, PhD, Department of Oncology Herlev Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

March 8, 2017

Study Completion (Actual)

March 8, 2017

Study Registration Dates

First Submitted

February 16, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A-14-1013-C-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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