ADC-1013 First-in-Human Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neoplasms, Solid Tumors

Intervention / Treatment
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* Biological: ADC-1013


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADC-1013 intratumoral<br>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<br>* Agonistic human monoclonal IgG1 anti-CD40 antibody<br>|
| Experimental: ADC-1013 intravenous<br>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<br>* Agonistic human monoclonal IgG1 anti-CD40 antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibodies, Antibodies, Monoclonal, Antineoplastic agent, Physiological effects of drugs, Therapeutic uses, Clinical Trial, Phase I, Immunotherapy, Active, CD40 Antigen, Immunologic Factors, Injections, Intralesional