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

A Phase 2 Study of VLS-101 in Patients With Solid Tumors

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%.

Participants enrolled prior to Amendment 3 will receive zilovertamab vedotin at 2.5 mg/kg given intravenously on Day 1 of repeated 21-day cycles. Participants enrolled after Amendment 3 will receive zilovertamab vedotin at 1.75 mg/kg given intravenously on Day 1 and Day 8 of repeated 21-day cycles. Treatment will continue until progressive disease or discontinuation.

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.