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

NCT04504916 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: 2140-002VLS-101-0003MK-2140-002
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 14

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 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%.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)- Blinded Independent Central Review (BICR)

  The percentage of participants who achieved a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \[SOD\] of target lesions) using per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 by BICR was reported.

  Up to ~18 months

Secondary Outcomes (26)

• ORR- Investigator Assessed

  Up to ~18 months

• Time to Response (TTR)- BICR

  Up to ~30 months

• Duration of Response (DOR)- BICR

  Up to ~30 months

• Progression-free Survival (PFS)- BICR

  Up to ~30 months

• Time to Treatment Failure (TTF)- BICR

  Up to ~30 months

Study Arms (1)

Zilovertamab Vedotin

EXPERIMENTAL

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

Drug: Zilovertamab vedotin

Interventions

Zilovertamab vedotin DRUG

Intravenous infusion

Also known as: MK-2140, VLS-101

Zilovertamab Vedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (14)

Memorial Regional Hospital-Memorial Cancer Institute ( Site 0005)

Hollywood, Florida, 33021, United States

Location

AdventHealth Orlando ( Site 0003)

Orlando, Florida, 32804, United States

Location

Massachusetts General Hospital ( Site 0017)

Boston, Massachusetts, 02114, United States

Location

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

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering Cancer Center ( Site 0007)

New York, New York, 10021, United States

Location

MD Anderson ( Site 0001)

Houston, Texas, 77030, United States

Location

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

San Antonio, Texas, 78229, United States

Location

Swedish Medical Center ( Site 0008)

Seattle, Washington, 98104, United States

Location

Cross Cancer Institute ( Site 0012)

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer Vancouver ( Site 0011)

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Princess Margaret Cancer Centre ( Site 0006)

Toronto, Ontario, M5G 2M9, Canada

Location

Centre intégré de cancérologie du CHUM ( Site 0016)

Montreal, Quebec, H2X 0A9, Canada

Location

Jewish General Hospital ( Site 0013)

Montreal, Quebec, H3T 1E2, Canada

Location

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

Québec, Quebec, G1J 1Z4, Canada

Location

Related Publications (2)

• 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.

  PMID: 40762544 RESULT

• 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.

  PMID: 34398557 DERIVED

Related Links

• Merck Oncology Clinical Trials Information

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Limitations and Caveats

Study terminated due to business reasons

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 7, 2020
• Study Start: October 7, 2020
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: November 10, 2025
• Results First Posted: August 15, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (6); US (8)