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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04504916
Recruitment Status : Active, not recruiting
First Posted : August 7, 2020
Last Update Posted : April 4, 2023
Sponsor:
Information provided by (Responsible Party):
VelosBio Inc.

Study Description
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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 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%.

Condition or disease Intervention/treatment Phase
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 Drug: Zilovertamab vedotin Phase 2

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 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of VLS-101 in Patients With Solid Tumors
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : July 17, 2023
Estimated Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Zilovertamab vedotin
Participants 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.
 Drug: Zilovertamab vedotin
Intravenous infusion
Other Names:
  • MK-2140
  • VLS-101


Outcome Measures
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Primary Outcome Measures :
  1. ORR [ Time Frame: Up to ~18 months ]
    The percentage of participants who achieve a complete response (CR) or partial response (PR) using per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 by Blinded Independent Central Review (BICR) will be reported.


Secondary Outcome Measures :
  1. ORR [ Time Frame: Up to ~18 months ]
    The percentage of participants who achieve a complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 by investigator will be reported.

  2. Time to response (TTR) [ Time Frame: Up to ~30 months ]
    TTR, defined as the time from the start of study treatment to the first documentation of objective tumor response will be reported.

  3. Duration of response (DOR) [ Time Frame: Up to ~30 months ]
    DOR, defined as the interval from the first documentation of objective tumor response to the earlier of the first documentation of disease progression or death from any cause will be reported.

  4. Progression-free survival (PFS) [ Time Frame: Up to ~30 months ]
    PFS, defined as the interval from the start of study treatment to the earlier of the first documentation of disease progression or death from any cause will be reported.

  5. Time to treatment failure (TTF) [ Time Frame: Up to ~30 months ]
    TTF, defined as the time from the start of study treatment to the earliest of the first documentation of disease progression, the permanent cessation of study drug due to an AE, or death from any cause will be reported.

  6. Overall survival (OS) [ Time Frame: Up to ~30 months ]
    OS, defined as the interval from the start of study treatment to death from any cause will be reported.

  7. Number of participants who experienced an adverse event (AE) [ Time Frame: Up to ~30 months ]
    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experienced an AE will be reported.

  8. Number of participants who discontinued study treatment due to an AE [ Time Frame: Up to ~30 months ]
    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinued study treatment due to an AE will be reported.

  9. Maximum plasma concentration (Cmax) of zilovertamab vedotin [ Time Frame: Pre-dose and post-dose on Day 1 and Day 8 of Cycle 1, and each subsequent cycle (up to ~30 months); Non-dose day samples on Day 15 of Cycle 1, Cycle 3, and at the end of treatment (up to ~30 months); each cycle = 21 days ]
    Cmax of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.

  10. Cmax of total antibody [ Time Frame: Pre-dose and post-dose on Day 1 and Day 8 of Cycle 1, and each subsequent cycle (up to ~30 months); Non-dose day samples on Day 15 of Cycle 1, Cycle 3, and at the end of treatment (up to ~30 months); each cycle = 21 days ]
    Cmax of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.

  11. Cmax of monomethyl auristatin E (MMAE) [ Time Frame: Pre-dose and post-dose on Day 1 and Day 8 of Cycle 1, and each subsequent cycle (up to ~30 months); Non-dose day samples on Day 15 of Cycle 1, Cycle 3, and at the end of treatment (up to ~30 months); each cycle = 21 days ]
    Cmax of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.

  12. Area under the plasma concentration-time curve (AUC) of zilovertamab vedotin [ Time Frame: Pre-dose and post-dose on Day 1 and Day 8 of Cycle 1, and each subsequent cycle (up to ~30 months); Non-dose day samples on Day 15 of Cycle 1, Cycle 3, and at the end of treatment (up to ~30 months); each cycle = 21 days ]
    AUC of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.

  13. AUC of total antibody [ Time Frame: Pre-dose and post-dose on Day 1 and Day 8 of Cycle 1, and each subsequent cycle (up to ~30 months); Non-dose day samples on Day 15 of Cycle 1, Cycle 3, and at the end of treatment (up to ~30 months); each cycle = 21 days ]
    AUC of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.

  14. AUC of MMAE [ Time Frame: Pre-dose and post-dose on Day 1 and Day 8 of Cycle 1, and each subsequent cycle (up to ~30 months); Non-dose day samples on Day 15 of Cycle 1, Cycle 3, and at the end of treatment (up to ~30 months); each cycle = 21 days ]
    AUC of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504916


Locations
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United States, Florida
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0005)
Hollywood, Florida, United States, 33021
AdventHealth Orlando ( Site 0003)
Orlando, Florida, United States, 32804
United States, Massachusetts
Massachusetts General Hospital ( Site 0017)
Boston, Massachusetts, United States, 02114
United States, New Jersey
John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0002)
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan Kettering Cancer Center ( Site 0007)
New York, New York, United States, 10021
United States, Texas
MD Anderson ( Site 0001)
Houston, Texas, United States, 77030
The University of Texas Health Science Center at San Antonio ( Site 0004)
San Antonio, Texas, United States, 78229
United States, Washington
Swedish Medical Center ( Site 0008)
Seattle, Washington, United States, 98104
Canada, Alberta
Cross Cancer Institute ( Site 0012)
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BC Cancer Vancouver ( Site 0011)
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Princess Margaret Cancer Centre ( Site 0006)
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre intégré de cancérologie du CHUM ( Site 0016)
Montreal, Quebec, Canada, H2X 0A9
Jewish General Hospital ( Site 0013)
Montreal, Quebec, Canada, H3T 1E2
Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
VelosBio Inc.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: VelosBio Inc.
ClinicalTrials.gov Identifier: NCT04504916    
Other Study ID Numbers: 2140-002
VLS-101-0003 ( Other Identifier: VelosBio )
MK-2140-002 ( Other Identifier: Merck )
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: April 4, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases