A Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients with Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Michelle A. Fanale
The goal of this clinical research study is to find the highest tolerable dose level of ADCT-301 that can be given to patients with different types of lymphoma. Researchers also want to learn if the highest dose found can help to control the disease. The safety of ADCT-301 will also be studied. This is the first study using ADCT-301 in humans.
Treatment Location: N/A
Primary Objectives -The primary objectives for Part 1 (dose escalation) and Part 2 (expansion) of the study are: • Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of ADCT-301 in patients with relapsed/refractory lymphoma (Part 1). • Determine the recommended dose of ADCT-301 for Part 2. • Evaluate the safety and tolerability of ADCT-301 in Part 2 at the dose level recommended in Part 1. Secondary Objectives The secondary objectives for Part 1 and Part 2 of the study are: Evaluate the activity of ADCT-301 measured by overall response rate, duration of response, progression-free survival, and overall survival. Characterize the pharmacokinetic (PK) profile of HuMax-TAC (total antibody drug-toantibody ratio [DAR] >/= 0), PBD-conjugated HuMax-TAC (DAR >/= 1), and free warhead SG3199. - Evaluate anti-drug antibodies (ADAs) in blood before, during, and after treatment with ADCT-301. Exploratory Objectives The exploratory objectives for Part 1 and Part 2 of the study are: - Evaluate the pharmacodynamic (PD) profile of ADCT-301 as measured by correlation between clinical activity and CD25 expression level in tumor tissue, and soluble CD25. - Evaluate the pharmacokinetic (PK) and PD relationship of ADCT-301. - Evaluate the change in white blood cell populations (such as activated T -cells) before, during, and after treatment with ADCT-301 (Study Part 2 only). - Explore the ADCT-301 and free warhead SG3199 concentration-QTc interval relationship.
IRB Review and Approval Date: 12/16/2015
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Michelle A. Fanale
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