Last updated on August 2019

Safety and Antitumor Activity Study of Loncastuximab Tesirine and Durvalumab in Diffuse Large B-Cell, Mantle Cell, or Follicular 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 Durvalumab in Patients with Advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or Follicular 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 75 patients.

A standard 3+3 dose escalation design will be used for Part 1. The DLT period will be the 21 days after the first durvalumab dose.

Part 2 will consist of up to 3 expansion cohorts, one for DLBCL, one for MCL, and one for FL. Each cohort will be approximately 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, 6' and 4 weeks), and a Follow-up Period (approximately every 12 week visits for up to 2 years after treatment discontinuation).

 

Clinical Study Identifier: TX216186

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Rutgers University

Located in New Brunswick, NJ United States
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University of Colorado Health Memorial Hospital

Located in Colorado Springs, CO United States
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Sylvester Comprehensive Cancer Center

Located in Miami, FL United States
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Icahn School of Medicine at Mount Sinai

Located in New York, NY United States
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Baylor University Medical Center

Located in Dallas, TX United States
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University of Florida Health Shands Cancer Hospital

Located in: Gainesville, FL United States
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Hospital Clinic de Barcelona

Located in Barcelona, Barcelona Spain
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Hospital Universitario Virgen Macarena

Located in Sevilla, SEVILLA SPAIN
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University of Alabama at Birmingham

Located in Birmingham, AL United States
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Hospital Universitario Virgen del Rocio

Located in Sevilla, ANDALUCIA ITALY
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