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 (CTRC# 15-2052
Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of ADCT-301 in patients with relapsed/refractory lymphoma
Determine the recommended dose of ADCT-301 for Part 2 (expansion).
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-to-antibody 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.
Evaluate the pharmacodynamic (PD) profile of ADCT-301 as measured by correlation between clinical activity and CD25 expression level in tumor tissue, soluble CD25, and DNA cross-links in blood.
Evaluate the 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 (Part 2 only).
Explore the ADCT-301 and free warhead SG3199 concentration-QTc interval relationship.