NCT02931110

Study of IV CBL0137 in Previously Treated Hematological Subjects

A Phase 1 Dose-Escalation and Cohort-Expansion Study of Intravenous CBL0137 in Subjects With Previously Treated Hematological Cancers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Incuron · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hematological Malignancies

Interventions

Type	Name	Description
DRUG	CBL0137	CBL0137 administered IV weekly on Days 1 and 8 of repeated 21 day treatment cycles. Number of Cycles: 2 or until progression or unacceptable toxicity develops

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2016-10-12
• Last updated: 2020-12-10

Locations

4 sites across 1 country: United States