GA NCORP

NCORP Trials

Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Status
Completed
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03589469
Protocol IDs
ADCT-402-201 (primary)
NCI-2018-01645
Study Sponsor
ADC Therapeutics S.A.

Summary

The purpose of this Phase 2 study is to evaluate the clinical efficacy and safety of
Loncastuximab Tesirine (ADCT-402) in patients with relapsed or refractory Diffuse Large
B-Cell Lymphoma.

Objectives

This is a Phase 2, multi-center, open-label, single-arm study of the efficacy and safety of
loncastuximab tesirine used as monotherapy in patients with relapsed or refractory DLBCL. The
study will enroll approximately 140 patients

Loncastuximab Tesirine is an antibody drug conjugate (ADC) composed of a humanized antibody
directed against human cluster of differentiation 19 (CD19), stochastically conjugated
through a cathepsin-cleavable linker to SG3199, a pyrrolobenzodiazepine (PBD) dimer
cytotoxin. Loncastuximab tesirine has been designed to target and kill CD19-expressing
malignant B-cells.

A 2-stage design will be used in this clinical study, with an interim analysis for futility
on the first 52 patients. If =10 patients respond (CR+PR), the study will proceed to complete
full enrollment. Enrollment will continue during the interim analysis; however, further
enrollment will be halted if futility is confirmed.

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

Patients may continue treatment until disease progression, unacceptable toxicity, or other
discontinuation criteria, whichever occurs first.

Treatment Sites


Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
Northside Hospital Central Research Department
404-303-3355
www.northside.com

Study Coordinator:
Stacey Brown
404-780-7965

Doctors:

Asad Bashey MD, PhD
H. Kent Holland MD
Lawrence E. Morris, Jr. MD
Scott R. Solomon MD
Melhem Solh MD