Breast Cancer Clinical Trial

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

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 breast cancer (TNBC), non-TNBC 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%.

View Full Description

Full 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 zilovertamab vedotin at 1.75 mg/kg given intravenously on Day 1 and Day 8 of repeated 21-day cycles. Participants enrolled after Amendment 4 will receive zilovertamab vedotin at 2.0 mg/kg given intravenously on Day 1 and Day 8 of repeated 21-day cycles. Treatment will continue until progressive disease or discontinuation.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

210

Study ID:

NCT04504916

Recruitment Status:

Recruiting

Sponsor:

VelosBio Inc.

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There are 14 Locations for this study

See Locations Near You

Memorial Regional Hospital-Memorial Cancer Institute ( Site 0005)
Hollywood Florida, 33021, United States More Info
Study Coordinator
Contact
954-265-1847
AdventHealth Orlando ( Site 0003)
Orlando Florida, 32804, United States More Info
Study Coordinator
Contact
407-303-2090
Massachusetts General Hospital ( Site 0017)
Boston Massachusetts, 02481, United States More Info
Study Coordinator
Contact
720-848-0030
John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0002)
Hackensack New Jersey, 07601, United States More Info
Study Coordinator
Contact
551-996-4725
Memorial Sloan Kettering Cancer Center ( Site 0007)
New York New York, 10021, United States More Info
Study Coordinator
Contact
646-888-5145
MD Anderson ( Site 0001)
Houston Texas, 77030, United States More Info
Study Coordinator
Contact
713-794-1226
The University of Texas Health Science Center at San Antonio ( Site 0004)
San Antonio Texas, 78229, United States More Info
Study Coordinator
Contact
210-450-5798
Swedish Medical Center ( Site 0008)
Seattle Washington, 98104, United States More Info
Study Coordinator
Contact
206-386-6443
Cross Cancer Institute ( Site 0012)
Edmonton Alberta, T6G 1, Canada More Info
Study Coordinator
Contact
7804328248
BC Cancer Vancouver ( Site 0011)
Vancouver British Columbia, V5Z 4, Canada More Info
Study Coordinator
Contact
6048776000 ext.2017
Princess Margaret Cancer Centre ( Site 0006)
Toronto Ontario, M5G 2, Canada More Info
Study Coordinator
Contact
416-946-4534
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0016)
Montreal Quebec, H2X 0, Canada More Info
Study Coordinator
Contact
5148908444
Jewish General Hospital ( Site 0013)
Montreal Quebec, H3T 1, Canada More Info
Study Coordinator
Contact
5143408222 24915
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Quebec , G1J 1, Canada More Info
Study Coordinator
Contact
4186915225

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

210

Study ID:

NCT04504916

Recruitment Status:

Recruiting

Sponsor:


VelosBio Inc.

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