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

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

  • 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

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 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

More Details

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

Study Contact

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.