Overview

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.