Study of IV CBL0137 in Previously Treated Hematological Subjects

Status Terminated

Clinical Trial Summary

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 intravenously (IV) administered CBL0137 in participants with previously treated hematological malignancies.

Clinical Trial Description

Part 1 of the study will evaluate the safety and pharmacology of a range of CBL0137 doses administered IV in participants with previously treated lymphomas, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), Hodgkin lymphoma (HL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), or multiple myeloma (MM). Cohorts of 3 to 6 subjects will be sequentially enrolled at progressively higher dose levels of CBL0137 using a standard 3+3 dose-escalation design. An additional 6 participants may be accrued at the maximum tolerated dose (MTD) or at the recommended dose (RD) to confirm CBL0137 safety and pharmacology as a prelude to further clinical evaluation. Part 2 of the study provides cohort expansion to further explore the safety, pharmacology, and clinical activity of CBL0137 monotherapy in participants with specific previously treated hematological cancers, including DLBCL, FL, MCL, HL, CLL/SLL, acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and MM. Twelve evaluable participants with each disease type may be enrolled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02931110
Study type	Interventional
Source	Incuron
Contact
Status	Terminated
Phase	Phase 1
Start date	January 2017
Completion date	October 2020

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