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


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

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society