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

Stopped early · Phase 2

Conditions studied: 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

In brief

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%.

Key facts

Study ID

NCT04504916

Run by

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

People needed

102

Starts

2020-10-07

Expected to finish

2023-06-12

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Memorial Regional Hospital-Memorial Cancer Institute ( Site 0005) — Hollywood, Florida, United States
• AdventHealth Orlando ( Site 0003) — Orlando, Florida, United States
• Massachusetts General Hospital ( Site 0017) — Boston, Massachusetts, United States
• John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0002) — Hackensack, New Jersey, United States
• Memorial Sloan Kettering Cancer Center ( Site 0007) — New York, New York, United States
• MD Anderson ( Site 0001) — Houston, Texas, United States
• The University of Texas Health Science Center at San Antonio ( Site 0004) — San Antonio, Texas, United States
• Swedish Medical Center ( Site 0008) — Seattle, Washington, United States
• Cross Cancer Institute ( Site 0012) — Edmonton, Alberta, Canada
• BC Cancer Vancouver ( Site 0011) — Vancouver, British Columbia, Canada
• Princess Margaret Cancer Centre ( Site 0006) — Toronto, Ontario, Canada
• Centre intégré de cancérologie du CHUM ( Site 0016) — Montreal, Quebec, Canada
• Jewish General Hospital ( Site 0013) — Montreal, Quebec, Canada
• Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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