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

Official Title

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

Summary:

This is a study evaluating the efficacy, safety, and pharmacokinetics of zilovertamab vedotin in participants with metastatic solid tumours 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%.

Trial Description

Primary Outcome:

• ORR

Secondary Outcome:

• ORR
• Time to response (TTR)
• Duration of response (DOR)
• Progression-free survival (PFS)
• Time to treatment failure (TTF)
• Overall survival (OS)
• Number of participants who experienced an adverse event (AE)
• Number of participants who discontinued study treatment due to an AE
• Maximum plasma concentration (Cmax) of zilovertamab vedotin
• Cmax of total antibody
• Cmax of monomethyl auristatin E (MMAE)
• Area under the plasma concentration-time curve (AUC) of zilovertamab vedotin
• AUC of total antibody
• AUC of MMAE

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.

View this trial on ClinicalTrials.gov