Status:
TERMINATED
A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)
Lead Sponsor:
VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Triple-negative Breast Cancer
Non-squamous Non-small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 breas...
Detailed Description
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 z...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2023
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04504916
Start Date
October 7 2020
End Date
June 12 2023
Last Update
November 7 2025
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0005)
Hollywood, Florida, United States, 33021
2
AdventHealth Orlando ( Site 0003)
Orlando, Florida, United States, 32804
3
Massachusetts General Hospital ( Site 0017)
Boston, Massachusetts, United States, 02114
4
John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0002)
Hackensack, New Jersey, United States, 07601