Clinical Trials Directory

Trials / Terminated

TerminatedNCT04504916

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

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
102 (actual)
Sponsor
VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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%.

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

Interventions

TypeNameDescription
DRUGZilovertamab vedotinIntravenous infusion

Timeline

Start date
2020-10-07
Primary completion
2023-06-12
Completion
2023-06-12
First posted
2020-08-07
Last updated
2025-11-10
Results posted
2024-08-15

Locations

14 sites across 2 countries: United States, Canada

Regulatory

Source: ClinicalTrials.gov record NCT04504916. Inclusion in this directory is not an endorsement.