Purpose

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%.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Zilovertamab vedotin
Participants will receive zilovertamab vedotin at 1.75 mg/kg given intravenously on Day 1 and Day 8 of repeated 21-day cycles. 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. Treatment will continue until progressive disease or discontinuation.
  • Drug: Zilovertamab vedotin
    Intravenous infusion of 1.75 mg/kg or 2.5 mg/kg
    Other names:
    • MK-2140
    • VLS-101

Recruiting Locations

The University of Texas Health Science Center at San Antonio ( Site 0004)
San Antonio, Texas 78229
Contact:
Study Coordinator
210-450-5798

More Details

Status
Recruiting
Sponsor
VelosBio Inc.

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@merck.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.