Triple-negative Breast CancerPhase 2NCT04504916

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

A Phase 2 study testing Zilovertamab vedotin in people with Triple-negative Breast Cancer and Non-squamous Non-small-cell Lung Cancer, run by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 14 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Triple-negative Breast Cancer, Non-squamous Non-small-cell Lung Cancer, NSCLC
What is being tested?: Zilovertamab vedotin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 14 sitesin 2 countries
Study dates: 7 Oct 2020to 12 Jun 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

14 sites in 2 countries.

Country

City, postcode or hospital

14 sites in 2 countries

United States8 sites

Massachusetts General Hospital ( Site 0017)
Boston, Massachusetts, 02114
John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0002)
Hackensack, New Jersey, 07601
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0005)
Hollywood, Florida, 33021
MD Anderson ( Site 0001)
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center ( Site 0007)
New York, New York, 10021
AdventHealth Orlando ( Site 0003)
Orlando, Florida, 32804
The University of Texas Health Science Center at San Antonio ( Site 0004)
San Antonio, Texas, 78229
Swedish Medical Center ( Site 0008)
Seattle, Washington, 98104

Other trials in United States

Canada6 sites

Cross Cancer Institute ( Site 0012)
Edmonton, Alberta, T6G 1Z2
Centre intégré de cancérologie du CHUM ( Site 0016)
Montreal, Quebec, H2X 0A9
Jewish General Hospital ( Site 0013)
Montreal, Quebec, H3T 1E2
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Québec, Quebec, G1J 1Z4
Princess Margaret Cancer Centre ( Site 0006)
Toronto, Ontario, M5G 2M9
BC Cancer Vancouver ( Site 0011)
Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Phase 2 Study of VLS-101 in Patients With Solid Tumors

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%.

Read the 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. Treatment will continue until progressive disease or discontinuation.

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
Being tested: Zilovertamab vedotin
Medical subject headings: Triple Negative Breast Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zilovertamab vedotinDrug
Also called MK-2140, VLS-101
Intravenous infusion

Study groups in NCT04504916
Study group	Role	What they receive
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 Receives: Drug: Zilovertamab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to ~18 months

Secondary outcomes (26)

ORR- Investigator Assessed
The percentage of participants who achieved a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters [SOD] of target lesions) per RECIST, Version 1.1 by investigator was reported.
Measured: Up to ~18 months
Time to Response (TTR)- BICR
TTR, defined as the time from the start of study treatment to the first documentation of objective tumor response per RECIST, Version 1.1 by BICR was reported.
Measured: Up to ~30 months
Duration of Response (DOR)- BICR
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 per RECIST, Version 1.1 by BICR was reported.
Measured: Up to ~30 months
Progression-free Survival (PFS)- BICR
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 per RECIST, Version 1.1 by BICR was reported.
Measured: Up to ~30 months
Time to Treatment Failure (TTF)- BICR
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 per RECIST, Version 1.1 by BICR was reported.
Measured: Up to ~30 months
Overall Survival (OS)
OS, defined as the interval from the start of study treatment to death from any cause will be reported.
Measured: Up to ~30 months
Number of Participants Who Experienced an Adverse Event (AE)
An AE was 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 was temporally associated with the use of the Sponsor's product, was also an AE. The number of participants who experienced an AE was reported.
Measured: Up to ~30 months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE was 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 was temporally associated with the use of the Sponsor's product, was also an AE. The number of participants who discontinued study treatment due to an AE was reported.
Measured: Up to ~11 months
Maximum Plasma Concentration (Cmax) of Zilovertamab Vedotin-Q1/3W Dosing Schedule
Cmax of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis.
Measured: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days
Cmax of Total Antibody-Q1/3W Dosing Schedule
Cmax of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis.
Measured: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days
Cmax of MMAE-Q1/3W Dosing Schedule
Cmax of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis.
Measured: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days
Area Under the Plasma Concentration-time Curve (AUC) 0-504hrs of Zilovertamab Vedotin- Q1/3W Dosing Schedule
AUC0-504hrs of Zilovertamab Vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis.
Measured: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days
AUC0-504hrs of Total Antibodies-Q1/3W Dosing Schedule
AUC0-504hrs of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis.
Measured: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days
AUC0-504hrs of MMAE-Q1/3W Dosing Schedule
AUC0-504hrs of MMAE by blood collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis.
Measured: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days
Cmax of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 1
Cmax of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.
Measured: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days
Cmax of Total Antibody-Q2/3W Dosing Schedule: Day 1
Cmax of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.
Measured: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days
Cmax of MMAE-Q2/3W Dosing Schedule: Day 1
Cmax of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.
Measured: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days
Cmax of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 8
Cmax of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.
Measured: Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days
Cmax of Total Antibody-Q2/3W Dosing Schedule: Day 8
Cmax of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.
Measured: Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days
Cmax of MMAE-Q2/3W Dosing Schedule: Day 8
Cmax of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.
Measured: Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days
AUC0-168hrs of Zilovertamab Vedotin -Q2/3W Dosing Schedule: Day 1
AUC0-168hrs of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.
Measured: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days
AUC0-168hrs of Total Antibody-Q2/3W Dosing Schedule: Day 1
AUC0-168hrs of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that is not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.
Measured: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days
AUC0-168 hr of MMAE-Q2/3W Dosing Schedule: Day 1
AUC0-168hrs of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.
Measured: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days
AUC168-336hrs of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 8
AUC168-336 hrs of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.
Measured: Day 8 [(predose; end of infusion (EOI)], Day 15 (168hr), Cycle 2 Day 1 Predose; each cycle=21 days
AUC168-336 Hrs of Total Antibody-Q2/3W Dosing Schedule: Day 8
AUC168-336hrs of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to MMAE. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis.
Measured: Day 8 [(predose; end of infusion (EOI)], Day 15 (168hr), Cycle 2 Day 1 Predose; each cycle=21 days
AUC168-336 hr of MMAE-Q2/3W Dosing Schedule: Day 8
AUC168-336 of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported.
Measured: Day 8 [(predose; end of infusion (EOI)], Day 15 (168hr), Cycle 2 Day 1 Predose; each cycle=21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 202012 Jun 2023

First posted7 Aug 2020
Study start7 Oct 2020
Primary completion12 Jun 2023
Study completion12 Jun 2023

Why it stopped: Business reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Triple-negative Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04504916
Sponsor's protocol ID: 2140-002
Other IDs: VLS-101-0003, MK-2140-002
Status last verified: Oct 2025
First submitted: 4 Aug 2020
Last updated: 10 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd

Publications

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.
PubMed 40762544
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.
PubMed 34398557

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study of VLS-101 in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT04504916
Acronym / sponsor ID: 2140-002
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
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business reasons
Enrolment: 102 participants (actual)
Lead sponsor: VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: 7 Oct 2020 (actual)
Primary completion: 12 Jun 2023 (actual)
Study completion: 12 Jun 2023 (actual)
First posted: 7 Aug 2020 (actual)
Results: Posted 15 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Zilovertamab Vedotin	Experimental	Drug: Zilovertamab vedotinParticipants 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zilovertamab vedotinAlso: MK-2140, VLS-101Intravenous infusion	Drug	Zilovertamab Vedotin

Primary outcome

Objective Response Rate (ORR)- Blinded Independent Central Review (BICR)
Time frame: Up to ~18 months
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.

26 secondary outcomes

ORR- Investigator Assessed
Time frame: Up to ~18 months
Time to Response (TTR)- BICR
Time frame: Up to ~30 months
Duration of Response (DOR)- BICR
Time frame: Up to ~30 months
Progression-free Survival (PFS)- BICR
Time frame: Up to ~30 months
Time to Treatment Failure (TTF)- BICR
Time frame: Up to ~30 months
Overall Survival (OS)
Time frame: Up to ~30 months
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to ~30 months
Number of Participants Who Discontinued Study Treatment Due to an AE
Time frame: Up to ~11 months
Maximum Plasma Concentration (Cmax) of Zilovertamab Vedotin-Q1/3W Dosing Schedule
Time frame: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days
Cmax of Total Antibody-Q1/3W Dosing Schedule
Time frame: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days
Cmax of MMAE-Q1/3W Dosing Schedule
Time frame: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days
Area Under the Plasma Concentration-time Curve (AUC) 0-504hrs of Zilovertamab Vedotin- Q1/3W Dosing Schedule
Time frame: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days
AUC0-504hrs of Total Antibodies-Q1/3W Dosing Schedule
Time frame: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days
AUC0-504hrs of MMAE-Q1/3W Dosing Schedule
Time frame: Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days
Cmax of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 1
Time frame: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days
Cmax of Total Antibody-Q2/3W Dosing Schedule: Day 1
Time frame: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days
Cmax of MMAE-Q2/3W Dosing Schedule: Day 1
Time frame: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days
Cmax of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 8
Time frame: Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days
Cmax of Total Antibody-Q2/3W Dosing Schedule: Day 8
Time frame: Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days
Cmax of MMAE-Q2/3W Dosing Schedule: Day 8
Time frame: Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days
AUC0-168hrs of Zilovertamab Vedotin -Q2/3W Dosing Schedule: Day 1
Time frame: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days
AUC0-168hrs of Total Antibody-Q2/3W Dosing Schedule: Day 1
Time frame: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days
AUC0-168 hr of MMAE-Q2/3W Dosing Schedule: Day 1
Time frame: Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days
AUC168-336hrs of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 8
Time frame: Day 8 [(predose; end of infusion (EOI)], Day 15 (168hr), Cycle 2 Day 1 Predose; each cycle=21 days
AUC168-336 Hrs of Total Antibody-Q2/3W Dosing Schedule: Day 8
Time frame: Day 8 [(predose; end of infusion (EOI)], Day 15 (168hr), Cycle 2 Day 1 Predose; each cycle=21 days
AUC168-336 hr of MMAE-Q2/3W Dosing Schedule: Day 8
Time frame: Day 8 [(predose; end of infusion (EOI)], Day 15 (168hr), Cycle 2 Day 1 Predose; each cycle=21 days

Results and safety

Results posted to the registry on 15 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zilovertamab Vedotin Q1/3W	70	0
Zilovertamab Vedotin Q2/3W	32	0

Primary outcome: Objective Response Rate (ORR)- Blinded Independent Central Review (BICR)

Time frame: Up to ~18 months. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Zilovertamab Vedotin Q1/3W n = 70	Zilovertamab Vedotin Q2/3W n = 32
Value	1.4 (0.0 to 7.7)	0.0 (NA to NA)

Population analysed: Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug

26 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 30 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zilovertamab Vedotin Q1/3W	29 of 70 (41.4%)	66 of 70 (94.3%)	54 of 70
Zilovertamab Vedotin Q2/3W	16 of 32 (50%)	30 of 32 (93.8%)	18 of 32

Limitations and caveats (from the sponsor): Study terminated due to business reasons

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 40762544Meric-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.
Derived from this study: PubMed 34398557Kipps 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.
Merck Oncology Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

14 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR)- Blinded Independent Central Review (BICR) (time frame: Up to ~18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04504916, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.