ADC-1013 First-in-Human Study

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

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.

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)