A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002) (NCT04504916) | Clinical Trial Compass
TerminatedPhase 2
A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)
Stopped: Business reasons
United States102 participantsStarted 2020-10-07
Plain-language 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%.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Objective Response Rate (ORR)- Blinded Independent Central Review (BICR)
Timeframe: Up to ~18 months
Trial details
NCT IDNCT04504916
SponsorVelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)