Skip to main content
OpenTrials
Completed

NCT Number: NCT02379741

ADC-1013 First-in-Human Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms Behavior Motor Activity Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Center for Cancer Research, Department of Oncology, Herlev Hospital, Herlev, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ADC-1013

Biological

Agonistic human monoclonal IgG1 anti-CD40 antibody

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Alligator Bioscience AB

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 5, 2015
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.