Last updated on January 2017

Study of IV CBL0137 in Previously Treated Hematological Subjects


Brief description of study

This clinical trial is a Phase 1, open-label, sequential-group, dose-escalation (Part 1) and cohort-expansion study (Part 2) evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of CBL0137. The study will evaluate CBL0137 administered IV weekly on Days 1 and 8 of repeated 21 day treatment cycles in subjects with previously treated hematological malignancies.

Detailed Study Description

Part 1 of the study will evaluate the safety and pharmacology of a range of CBL0137 doses administered IV in subjects with previously treated lymphomas, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), or Hodgkin lymphoma (HL). Part 2 of the study provides cohort expansion to further explore the safety, pharmacology, and clinical activity of CBL0137 monotherapy in subjects with specific previously treated hematological cancers, including DLBCL, FL, MCL, HL, chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and multiple myeloma (MM).

Clinical Study Identifier: NCT02931110

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Claude Sportes, MD

Claude Sportes
Augusta, GA United States
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