ADC-1013 First-in-Human Study

Alligator Bioscience

Status and phase: Completed; Phase 1

Conditions: Neoplasms; Solid Tumors

Treatments: Biological: ADC-1013

Study type: Interventional

Funder types: Industry

Identifiers

NCT02379741

A-14-1013-C-01

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

ADC-1013 intratumoral

Experimental group

Description:

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.

Treatment:

Biological: ADC-1013

ADC-1013 intravenous

Experimental group

Description:

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.

Treatment:

Biological: ADC-1013