NCT03833180

A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001)

A Phase 1 Dose-Escalation and Cohort-Expansion Study of VLS-101 in Subjects With Hematological Malignancies (waveLINE-001)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, immunogenicity, and efficacy of zilovertamab vedotin given intravenously (IV) across a range of dose levels in participants with previously treated hematological cancers including acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), Burkitt lymphoma (BL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), Richter transformation lymphoma (RTL), and T-cell non-Hodgkin lymphoma (NHL).

Conditions

• Chronic Lymphocytic Leukemia
• Mantle Cell Lymphoma
• Follicular Lymphoma
• Marginal Zone Lymphoma
• Diffuse Large B-cell Lymphoma
• Richter Transformation Lymphoma
• Burkitt Lymphoma
• Lymphoplasmacytoid Lymphoma
• T-cell Non-Hodgkin Lymphoma
• Acute Lymphoid Leukemia
• Acute Myeloid Leukemia
• Waldenstrom Macroglobulinemia

Interventions

Type	Name	Description
DRUG	Zilovertamab vedotin	Zilovertamab vedotin administered via IV infusion per Schedule 1, 2, or 3 according to participant allocation.

Timeline

• Start date: 2019-03-14
• Primary completion: 2023-12-18
• Completion: 2023-12-18
• First posted: 2019-02-06
• Last updated: 2024-01-12

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study