A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)

Study 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%.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedZilovertamab vedotin

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 10, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?14 U.S. locations

Locations may change over time.

Who runs it?VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Study sponsor

Study overview

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

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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