A phase 1 adaptive dose-escalation study to evaluate the tolerability, safety, pharmacokinetics, and antitumor activity of ADCT-402 in patients with relapsed or refractory B-cell lineage non Hodgkin lymphoma (B-NHL).

Authors

null

Ki Y. Chung

GHS Cancer Inst / ITOR, Spartanburg, SC

Ki Y. Chung , Mehdi Hamadani , Brad S. Kahl , Leonard T. Heffner , Paolo Fabrizio Caimi , Jay Marshall Feingold , Owen A. O'Connor

Organizations

GHS Cancer Inst / ITOR, Spartanburg, SC, Division of Hematology and Oncology - Medical College of Wisconsin, Milwaukee, WI, University of Wisconsin Carbone Cancer Center, Madison, WI, Emory University - Winship Cancer Institute, Atlanta, GA, University Hospitals Seidman Cancer Center, Case Western Reserve University, and Case Comprehensive Cancer Center, Cleveland, OH, ADC Therapeutics, Livingston, NJ, Columbia University Medical Center, New York, NY

Research Funding

Pharmaceutical/Biotech Company

Background: In normal human tissue, expression of cluster of differentiation 19 (CD19) is limited to the developmental stages of the B cell and is lost in terminally differentiated plasma cells. Expression of CD19 is maintained in hematologic B-cell malignancies, including B-NHL. ADCT-402 is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody (RB4v1.2), directed against human CD19, conjugated to SG3199, a pyrrolobenzodiazepine (PBD) dimer cytotoxin, through a protease-cleavable valine-alanine linker. The PBD dimer cytotoxin (SG3199) attached to the linker is designated as SG3249. Methods: This is a Phase 1, open-label, dose escalation (Part 1) and expansion (Part 2) study of the safety and tolerability of ADCT-402, used as monotherapy, in patients with relapsed or refractory B-NHL. The study will determine the maximum tolerated dose, as well as evaluate the preliminary activity, PK, pharmacodynamics (PD), and other exploratory assessments of ADCT-402. Patients will be assigned to treatment according to a modified continual reassessment method (mCRM) with oversight by a Dose Escalation Steering Committee (DESC). In Part 2, all patients will be assigned to the dose level of ADCT-402 identified in Part 1. Clinical trial information: NCT02669017

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Track

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Sub Track

Non-Hodgkin Lymphoma

Clinical Trial Registration Number

NCT02669017

Citation

J Clin Oncol 34, 2016 (suppl; abstr TPS7580)

DOI

10.1200/JCO.2016.34.15_suppl.TPS7580

Abstract #

TPS7580

Poster Bd #

132a

Abstract Disclosures