Neoplasms, Solid Tumors
Conditions
Keywords
Antibodies, Antibodies, Monoclonal, Antineoplastic agent, Physiological effects of drugs, Therapeutic uses, Clinical Trial, Phase I, Immunotherapy, Active, CD40 Antigen, Immunologic Factors, Injections, Intralesional
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.
Interventions
BIOLOGICALADC-1013
Agonistic human monoclonal IgG1 anti-CD40 antibody
Sponsors
Alligator Bioscience AB
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
Countries
Denmark, Sweden, United Kingdom
Outcome results
None listed