A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)
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%.
Checked against the public recordLast updated Nov 10, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Interventions being studied
- Drug: Zilovertamab vedotin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Has a confirmed diagnosis of solid tumor for one of the following types of cancer: previously treated cancers of triple-negative breast cancer (TNBC), non-TNBC HER2-negative breast cancer, non-squamous non-small-cell lung cancer (NSCLC), gastric cancer, pancreatic cancer, or platinum-resistant ovarian cancer. * Has metastatic disease that has progressed during or following previous treatment appropriate for the disease type * Presence of radiographically measurable disease. * Is willing to provide tumor tissue * Has adequate organ function * Has a negative test or adequate therapy for human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C. * Has completed all prior therapy. * Female subjects of childbearing potential must have a negative serum pregnancy test. * Both male and female subjects must be willing to use adequate contraception. Exclusion Criteria: * Has peripheral neuropathy of Grade \>1. * Has a malignancy involving the central nervous system. * Has another major cancer. * Has an uncontrolled ongoing infection. * Has significant cardiovascular disease. * Has a known diagnosis of liver cirrhosis. * Is pregnant or breastfeeding. * Has had major surgery within 4 weeks before the start of study therapy. * Has known tumor resistance or intolerance to a prior MMAE-containing drug. * Is concurrently participating in another therapeutic or imaging clinical trial.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Memorial Regional Hospital-Memorial Cancer Institute ( Site 0005)Hollywood, Florida
- AdventHealth Orlando ( Site 0003)Orlando, Florida
- Massachusetts General Hospital ( Site 0017)Boston, Massachusetts
- John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0002)Hackensack, New Jersey
- Memorial Sloan Kettering Cancer Center ( Site 0007)New York, New York
- MD Anderson ( Site 0001)Houston, Texas
- The University of Texas Health Science Center at San Antonio ( Site 0004)San Antonio, Texas
- Swedish Medical Center ( Site 0008)Seattle, Washington
- Cross Cancer Institute ( Site 0012)Edmonton, Alberta
- BC Cancer Vancouver ( Site 0011)Vancouver, British Columbia
- Princess Margaret Cancer Centre ( Site 0006)Toronto, Ontario
- Centre intégré de cancérologie du CHUM ( Site 0016)Montreal, Quebec
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 10, 2025. Always confirm current availability with the study team.