A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)
NCT04504916 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2025-11-10
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%.
Conditions
- Triple-negative Breast Cancer
- Non-squamous Non-small-cell Lung Cancer
- NSCLC
- Estrogen-receptor-positive Breast Cancer
- Progesterone-receptor-positive Breast Cancer
- Estrogen-receptor-negative Breast Cancer
- ER-negative Breast Cancer
- Progesterone-receptor Negative Breast Cancer
- PR-negative Breast Cancer
- HER2-negative Breast Cancer
- ER-positive Breast Cancer
- PR-positive Breast Cancer
- Platinum-resistant Ovarian Cancer
- Gastric Cancer
- Pancreatic Cancer
Interventions
- DRUG
-
Zilovertamab vedotin
Intravenous infusion
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
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-07
- Primary Completion
- 2023-06-12
- Completion
- 2023-06-12
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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