ADC-1013 First-in-Human Study

Phase 1

Completed

• Conditions: Neoplasms; Solid Tumors
• Interventions: Biological: ADC-1013

• Registration Number: NCT02379741
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-16
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-05
• Study Start: 2015-04
• Status Verified: 2017-03
• Primary Completion: 2017-03-08
• Study Completion: 2017-03-08
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADC-1013 intravenous	ADC-1013	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.
ADC-1013 intratumoral	ADC-1013	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.

Primary Outcome Measures

Name	Time	Method
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.	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

Name	Time	Method
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).	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	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.	From start of study until end of study (appr 28 days after last dose)

Trial Locations

Locations (5)

Kliniska prövningsenheten (KPE), Karolinska University Hospital; 🇸🇪 Solna, Stockholm, Sweden

Center for Cancer Research, Department of Oncology, Herlev Hospital; 🇩🇰 Herlev, Denmark

The Clatterbridge Cancer Centre; 🇬🇧 Bebington, Wirral, United Kingdom

Department of Oncology, Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Department of Oncology, Queen Elisabeth Hospital; 🇬🇧 Edgbaston, Birmingham, United Kingdom