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

NCT ID: NCT04504916

Last Updated: 2025-11-10

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-07

Study Completion Date

2023-06-12

Brief Summary

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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%.

Detailed Description

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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.

Conditions

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Triple-negative Breast Cancer Non-squamous Non-small-cell Lung Cancer NSCLC Estrogen-receptor-positive Breast Cancer Progesterone-receptor-positive Breast Cancer Estrogen-receptor-negative Breast Cancer ER-negative Breast Cancer Progesterone-receptor Negative Breast Cancer PR-negative Breast Cancer HER2-negative Breast Cancer ER-positive Breast Cancer PR-positive Breast Cancer Platinum-resistant Ovarian Cancer Gastric Cancer Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zilovertamab Vedotin

Participants will receive intravenous (IV) zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W) or 1.75 mg/kg on Day 1 and Day 8 of each 21-day cycle (Q2/3W). Treatment will continue until progressive disease or discontinuation

Group Type EXPERIMENTAL

Zilovertamab vedotin

Intervention Type DRUG

Intravenous infusion

Interventions

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Zilovertamab vedotin

Intravenous infusion

Intervention Type DRUG

Other Intervention Names

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MK-2140 VLS-101

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Memorial Regional Hospital-Memorial Cancer Institute ( Site 0005)

Hollywood, Florida, United States

Site Status

AdventHealth Orlando ( Site 0003)

Orlando, Florida, United States

Site Status

Massachusetts General Hospital ( Site 0017)

Boston, Massachusetts, United States

Site Status

John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0002)

Hackensack, New Jersey, United States

Site Status

Memorial Sloan Kettering Cancer Center ( Site 0007)

New York, New York, United States

Site Status

MD Anderson ( Site 0001)

Houston, Texas, United States

Site Status

The University of Texas Health Science Center at San Antonio ( Site 0004)

San Antonio, Texas, United States

Site Status

Swedish Medical Center ( Site 0008)

Seattle, Washington, United States

Site Status

Cross Cancer Institute ( Site 0012)

Edmonton, Alberta, Canada

Site Status

BC Cancer Vancouver ( Site 0011)

Vancouver, British Columbia, Canada

Site Status

Princess Margaret Cancer Centre ( Site 0006)

Toronto, Ontario, Canada

Site Status

Centre intégré de cancérologie du CHUM ( Site 0016)

Montreal, Quebec, Canada

Site Status

Jewish General Hospital ( Site 0013)

Montreal, Quebec, Canada

Site Status

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

References

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Meric-Bernstam F, Gutierrez M, Sanz-Garcia E, Villa D, Zhang J, Friedmann J, Yan F, Socinski MA, Sarantopoulos J, Raez LE, Chu QS, Chenard-Poirier M, Chatterjee MS, Ren H, Liu Q, Levine DA, Jhaveri KL. Phase 2 Study of Zilovertamab Vedotin in Participants with Metastatic Solid Tumors. Cancer Res Commun. 2025 Sep 1;5(9):1664-1673. doi: 10.1158/2767-9764.CRC-25-0019.

Reference Type RESULT
PMID: 40762544 (View on PubMed)

Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.

Reference Type DERIVED
PMID: 34398557 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://merckoncologyclinicaltrials.com

Merck Oncology Clinical Trials Information

Other Identifiers

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VLS-101-0003

Identifier Type: OTHER

Identifier Source: secondary_id

MK-2140-002

Identifier Type: OTHER

Identifier Source: secondary_id

2140-002

Identifier Type: -

Identifier Source: org_study_id