NCT02379741

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2015

Typical duration for phase_1

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

February 16, 2015

Last Update Submit

March 23, 2017

Conditions

NeoplasmsSolid Tumors

Keywords

AntibodiesAntibodies, MonoclonalAntineoplastic agentPhysiological effects of drugsTherapeutic usesClinical Trial, Phase IImmunotherapy, ActiveCD40 AntigenImmunologic FactorsInjections, Intralesional

Outcome Measures

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.

    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 Outcomes (3)

  • 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)

Study Arms (2)

ADC-1013 intratumoral

EXPERIMENTAL

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

ADC-1013 intravenous

EXPERIMENTAL

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

Interventions

ADC-1013BIOLOGICAL

Agonistic human monoclonal IgG1 anti-CD40 antibody

ADC-1013 intratumoralADC-1013 intravenous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of advanced solid tumor disease
  • Performance status of 0-1 on the ECOG scale
  • Life expectancy of at least 3 months

You may not qualify if:

  • Organ transplant recipient
  • Autoimmune disorder
  • Other malignancy (except localized prostate cancer, adequately treated basal skin cancer or carcinoma in-situ of the cervix)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Center for Cancer Research, Department of Oncology, Herlev Hospital

Herlev, Herlev, DK-2730, Denmark

Location

Kliniska prövningsenheten (KPE), Karolinska University Hospital

Solna, Stockholm County, SE-171 76, Sweden

Location

Department of Oncology, Uppsala University Hospital

Uppsala, Uppsala County, SE-751 85, Sweden

Location

Department of Oncology, Queen Elisabeth Hospital

Edgbaston, Birmingham, B15 2TH, United Kingdom

Location

The Clatterbridge Cancer Centre

Bebington, Wirral, CH63 4JY, United Kingdom

Location

MeSH Terms

Conditions

NeoplasmsMotor Activity

Interventions

mitazalimab

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Per Norlén, MD, PhD

    Alligator Biosciene AB, Sweden

    STUDY DIRECTOR

  • Dorte Nielsen, MD, PhD

    Department of Oncology Herlev Hospital, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2015

First Posted

March 5, 2015

Study Start

April 1, 2015

Primary Completion

March 8, 2017

Study Completion

March 8, 2017

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

SE(2)DK(1)GB(2)