A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001)
NCT03833180 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 91
Last updated 2024-01-12
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
- DRUG
-
Zilovertamab vedotin
Zilovertamab vedotin administered via IV infusion per Schedule 1, 2, or 3 according to participant allocation.
Sponsors & Collaborators
-
VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-14
- Primary Completion
- 2023-12-18
- Completion
- 2023-12-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
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