drugset / Trial / NCT04504916
A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)
Phase 2
Terminated
102 enrolled
VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
NaSingle-groupOpen-labelTreatment
Summary
This is a study evaluating the efficacy, safety, and pharmacokinetics of zilovertamab vedotin in participants with metastatic solid tumors including previously treated cancers of triple-negative breast cancer (TNBC), non-TNBC human epidermal growth factor receptor 2 (HER2)-negative breast cancer, non-squamous non-small-cell lung cancer (NSCLC), gastric cancer, pancreatic cancer, and platinum-resistant ovarian cancer. The study will evaluate a null hypothesis that the objective response rate (ORR) is ≤5% against the alternative hypothesis that it is ≥20%.
Timeline
- Start
- 2020-10-07
- Primary completion
- 2023-06-12
- Completion
- 2023-06-12
Publications
- Results Meric-Bernstam F, Gutierrez M, Sanz-Garcia E, Villa D, Zhang J, Friedmann J, Yan F, Socinski MA, Sarantopoulos J, Raez LE, Chu QS, Chenard-Poirier M, Chatterjee MS, Ren H, Liu Q, Levine DA, Jhaveri KL. Phase 2 Study of Zilovertamab Vedotin in Participants with Metastatic Solid Tumors. Cancer Res Commun. 2025 Sep 1;5(9):1664-1673. doi: 10.1158/2767-9764.CRC-25-0019.
- 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 | 1.75 mg/kg | Intravenous |
| Subject | Zilovertamab vedotin | Unknown | 2.5 mg/kg | Intravenous |