ADC-1013 First-in-Human Study

Alligator Bioscience AB24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms Solid Tumors

Interventions

ADC-1013BIOLOGICAL

Agonistic human monoclonal IgG1 anti-CD40 antibody

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (5)

Center for Cancer Research, Department of Oncology, Herlev Hospital

Herlev, Herlev, Denmark

Kliniska prövningsenheten (KPE), Karolinska University Hospital

Solna, Stockholm County, Sweden

Department of Oncology, Uppsala University Hospital

Uppsala, Uppsala County, Sweden

Department of Oncology, Queen Elisabeth Hospital

Edgbaston, Birmingham, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: From start of study until end of study (appr 28 days after last dose)

Secondary Outcomes

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

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)

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)

Data from ClinicalTrials.gov

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