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

• Status: Recruiting
• Trial end date: 2023-04-28
• Target enrollment: 0
• Participant gender: All

Summary

This is a study evaluating the efficacy, safety, pharmacokinetics, immunogenicity, and pharmacodynamics of zilovertamab vedotin in participants with metastatic solid tumors including triple-negative breast cancer (TNBC), non-squamous non-small-cell lung cancer (NSCLC), estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer and human epidermal growth factor 2 positive carcinoma of breast.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VelosBio Inc.

Criteria

Inclusion Criteria:

• Has a confirmed diagnosis of solid tumor.

• 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.