Last updated on May 2019

Safety and Antitumor Activity Study of Loncastuximab Tesirine + Ibrutinib in Diffuse Large B-Cell or Mantle Cell Lymphoma


Brief description of study

The purpose of this Phase 1 study is to evaluate the safety and antitumor activity of Loncastuximab Tesirine (ADCT-402) and Ibrutinib in patients with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma.

 

Detailed Study Description

This is a Phase 1b, open-label, single-arm combination study with a dose escalation phase (Part 1) followed by a dose expansion phase (Part 2). The study will enroll approximately 60 patients.

A standard 3+3 dose escalation design will be used for Part 1. The DLT period will be the 21 days following the first dose of ibrutinib. The initial dose escalation cohort will receive loncastuximab tesirine for 2 cycles with concurrent ibrutinib (concomitant therapy) and may then continue ibrutinib therapy up to one year. Depending on the safety and tolerability of loncastuximab tesirine given concurrently with ibrutinib in the initial cohort, subsequent cohorts may receive either loncastuximab tesirine with concurrent ibrutinib or loncastuximab tesirine followed by ibrutinib (sequential therapy).

Patients who have a response of PR or stable disease (SD) at the 14-week assessment may receive two additional doses of loncastuximab tesirine given 4 weeks apart.

Part 2 will consist of up to two expansion cohorts, one for DLBCL and one for MCL. Each cohort will be 20 patients treated at the dose determined in Part 1.

The study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 3 to 4 weeks), and a Follow-up Period (approximately every 12 week visits for up to 2 years after treatment discontinuation).

 

Clinical Study Identifier: TX216185

Find a site near you

Start Over

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.