ADC-1013 First-in-Human Study

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379741
• Other study ID #: A-14-1013-C-01
• Status: Completed
• Phase: Phase 1
• First received: February 16, 2015
• Last updated: March 23, 2017
• Start date: April 2015
• Est. completion date: March 8, 2017

Study information

• Verified date: March 2017
• Source: Alligator Bioscience AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 8, 2017
• Est. primary completion date: March 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Biological:
• ADC-1013
Agonistic human monoclonal IgG1 anti-CD40 antibody

Locations

Country	Name	City	State
Denmark	Center for Cancer Research, Department of Oncology, Herlev Hospital	Herlev
Sweden	Kliniska prövningsenheten (KPE), Karolinska University Hospital	Solna	Stockholm
Sweden	Department of Oncology, Uppsala University Hospital	Uppsala
United Kingdom	The Clatterbridge Cancer Centre	Bebington	Wirral
United Kingdom	Department of Oncology, Queen Elisabeth Hospital	Edgbaston	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Alligator Bioscience AB

Countries where clinical trial is conducted

Denmark,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Pharmacokinetics of ADC-1013 after single and repeated administrations assessed by the following parameters: Cmax, Tmax, elimination half-life, AUC0-8, total serum clearance (CL) and the volume of distribution at steady state (Vss).		From first dose until 55 days after first dose
Secondary	Immunogenicity of ADC-1013 after repeated administrations assessed by anti-drug antibody (ADA) titers in serum		From first dose until end of study (appr 28 days after last dose)
Secondary	Clinical efficacy (i.e. anti-tumor activity) of ADC-1013 assessed by immune-related RECIST (irRECIST) and RECIST 1.1.		From start of study until end of study (appr 28 days after last dose)