drugset / Trial / NCT03833180
A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001)
Phase 1
Completed
91 enrolled
VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Non-randomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2019-03-14
- Primary completion
- 2023-12-18
- Completion
- 2023-12-18
Publications
- Results Wang ML, Barrientos JC, Furman RR, Mei M, Barr PM, Choi MY, de Vos S, Kallam A, Patel K, Kipps TJ, Rule S, Flanders K, Jessen KA, Ren H, Riebling PC, Graham P, King L, Thurston AW, Sun M, Schmidt EM, Lannutti BJ, Johnson DM, Miller LL, Spurgeon SE. Zilovertamab Vedotin Targeting of ROR1 as Therapy for Lymphoid Cancers. NEJM Evid. 2022 Jan;1(1):EVIDoa2100001. doi: 10.1056/EVIDoa2100001. Epub 2021 Oct 12.
- Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zilovertamab vedotin | Unknown | 0.5 mg/kg | Intravenous |
| Subject | Zilovertamab vedotin | Unknown | 0.75 mg/kg | Intravenous |
| Subject | Zilovertamab vedotin | Unknown | 1 mg/kg | Intravenous |
| Subject | Zilovertamab vedotin | Unknown | 1.25 mg/kg | Intravenous |
| Subject | Zilovertamab vedotin | Unknown | 1.5 mg/kg | Intravenous |
| Subject | Zilovertamab vedotin | Unknown | 1.75 mg/kg | Intravenous |
| Subject | Zilovertamab vedotin | Unknown | 2 mg/kg | Intravenous |
| Subject | Zilovertamab vedotin | Unknown | 2.25 mg/kg | Intravenous |
| Subject | Zilovertamab vedotin | Unknown | 2.5 mg/kg | Intravenous |
| Subject | Zilovertamab vedotin | Unknown | 2.75 mg/kg | Intravenous |
| Subject | Zilovertamab vedotin | Unknown | 3 mg/kg | Intravenous |