A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Solid Tumors (MK-2140-002)
Purpose
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 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
- Triple-negative Breast Cancer
- Non-squamous Non-small-cell Lung Cancer
- NSCLC
- Estrogen-receptor-positive Breast Cancer
- Progesterone-receptor-positive Breast Cancer
- Estrogen-receptor-negative Breast Cancer
- ER-negative Breast Cancer
- Progesterone-receptor Negative Breast Cancer
- PR-negative Breast Cancer
- HER2-negative Breast Cancer
- ER-positive Breast Cancer
- PR-positive Breast Cancer
- Platinum-resistant Ovarian Cancer
- Gastric Cancer
- Pancreatic Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Zilovertamab vedotin |
Participants will receive zilovertamab vedotin at 2.0 mg/kg given intravenously on Day 1 and Day 8 of repeated 21-day cycles. Treatment will continue until progressive disease or discontinuation. |
|
More Details
- Status
- Completed
- Sponsor
- VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study Contact
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. Participants enrolled after Amendment 4 will receive zilovertamab vedotin at 2.0 mg/kg given intravenously on Day 1 and Day 8 of repeated 21-day cycles. Treatment will continue until progressive disease or discontinuation.