Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business reasons
Summary
Brief summary (as posted)
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%.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ER-negative Breast Cancer | — | UNRESOLVED | — |
| ER-positive Breast Cancer | — | UNRESOLVED | — |
| Estrogen-receptor-negative Breast Cancer | — | UNRESOLVED | — |
| Estrogen-receptor-positive Breast Cancer | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
| Non-squamous Non-small-cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zilovertamab vedotin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zilovertamab Vedotin
- description
- Participants will receive intravenous (IV) zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W) or 1.75 mg/kg on Day 1 and Day 8 of each 21-day cycle (Q2/3W). Treatment will continue until progressive disease or discontinuation
- interventionNames
- Drug: Zilovertamab vedotin
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)- Blinded Independent Central Review (BICR)
- timeFrame
- Up to ~18 months
- description
- The percentage of participants who achieved a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \[SOD\] of target lesions) using per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 by BICR was reported.
Secondary outcomes (26)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTMeric-Bernstam F, Gutierrez M, Sanz-Garcia E, Villa D, Zhang J, Friedmann J, Yan F, Socinski MA, Sarantopoulos J, Raez LE, Chu QS, Chenard-Poirier M, Chatterjee MS, Ren H, Liu Q, Levine DA, Jhaveri KL. Phase 2 Study of Zilovertamab Vedotin in Participants with Metastatic Solid Tumors. Cancer Res Commun. 2025 Sep 1;5(9):1664-1673. doi: 10.1158/2767-9764.CRC-25-0019. PMID 40762544
- DERIVEDKipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536. PMID 34398557