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Antibody-drug conjugate

Zilovertamab vedotin for Waldenstrom Macroglobulinemia

Phase 1
Waitlist Available
Research Sponsored by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hematological cancer under study has been previously treated and has progressed during or relapsed after prior systemic therapy
Hematological cancer is unlikely to be responsive to established therapies known to provide clinical benefit or the study candidate has developed an intolerance to established therapies known to provide clinical benefit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3.5 years
Awards & highlights

Study Summary

This trial is studying zilovertamab vedotin to see how well it works in treating patients with hematological cancers that have come back or have not responded to previous treatment.

Who is the study for?
Adults (≥18 years) with certain types of blood cancers that have progressed after treatment can join this trial. They must have measurable cancer, resolved side effects from previous treatments, and proper organ function. Pregnant or breastfeeding individuals, those with significant heart disease, CNS malignancies, uncontrolled infections, liver cirrhosis, or recent major surgery cannot participate.Check my eligibility
What is being tested?
The study is testing Zilovertamab vedotin given intravenously to people with various hematological cancers like leukemia and lymphoma. It aims to assess the drug's safety and effectiveness at different doses in patients who've had prior treatments but need more due to progressing disease.See study design
What are the potential side effects?
Potential side effects of Zilovertamab vedotin may include reactions at the infusion site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems. Organ-specific inflammation could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a type of blood cancer that has been treated in the past but has gotten worse or come back after treatment.
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If you have a type of blood cancer that is unlikely to respond to current treatments or if you have had bad reactions to previous treatments that are known to be effective.
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You currently need medical treatment because of symptoms or complications caused by your disease, low blood cell counts, enlarged lymph nodes or organs, involvement of organs outside of lymph nodes, or your disease is getting worse over time.
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You have been treated with a medication that contains MMAE before, and that's okay.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) of zilovertamab vedotin
Recommended Dosing Regimen (RDR)
Secondary outcome measures
AUC of MMAE
AUC of total UC-961 antibody
Apparent terminal half-life (t½) of plasma concentration of zilovertamab vedotin
+34 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Zilovertamab vedotin Schedule 3: Q3/4WExperimental Treatment1 Intervention
Participants will be administered escalating doses of zilovertamab vedotin at 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, and 2.25 mg/kg IV on Day 1, 8, and 15 of repeated 21-day cycles (Q3/4W).
Group II: Zilovertamab vedotin Schedule 2: Q2/3WExperimental Treatment1 Intervention
Participants will be administered escalating doses of zilovertamab vedotin at 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, and 2.25 mg/kg IV on Day 1 and 8 of repeated 21-day cycles (Q2/3W).
Group III: Zilovertamab vedotin Schedule 1: Q1/3WExperimental Treatment1 Intervention
Participants will be administered escalating doses of zilovertamab vedotin at 0.50, 1.00, 1.50, 2.25, 2.50, 2.75, and 3.00 mg/kg IV on Day 1 of repeated 21-day cycles (Q1/3W).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zilovertamab vedotin
2019
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Lead Sponsor
1 Previous Clinical Trials
102 Total Patients Enrolled
VelosBio Inc.Lead Sponsor
1 Previous Clinical Trials
102 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,062,109 Total Patients Enrolled
2 Trials studying Waldenstrom Macroglobulinemia
640 Patients Enrolled for Waldenstrom Macroglobulinemia

Media Library

Zilovertamab vedotin (Antibody-drug conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03833180 — Phase 1
Waldenstrom Macroglobulinemia Research Study Groups: Zilovertamab vedotin Schedule 3: Q3/4W, Zilovertamab vedotin Schedule 1: Q1/3W, Zilovertamab vedotin Schedule 2: Q2/3W
Waldenstrom Macroglobulinemia Clinical Trial 2023: Zilovertamab vedotin Highlights & Side Effects. Trial Name: NCT03833180 — Phase 1
Zilovertamab vedotin (Antibody-drug conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03833180 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA authorized Zilovertamab vedotin for public use?

"The safety rating of Zilovertamab vedotin is assessed as a 1 due to the limited clinical evidence available from Phase 1 trials."

Answered by AI

How many research centers are conducting the trial?

"Patients can participate in this clinical trial at Swedish Medical Center (Site 0002) located in Seattle, Washington; City of Hope National Medical Centre situated in Duarte, Texas; and UC San Diego Moores Cancer Centre based out of Los Angeles, Virginia. Additionally there are 24 other sites recruiting patients for the study."

Answered by AI

What projected effects are researchers seeking to achieve through this research?

"As disclosed by the trial sponsor, VelosBio Inc., the primary outcome evaluated over a 21-day period is Maximum Tolerated Dose (MTD) of VLS-101. Secondary outcomes being analyzed include tumour response based on established criteria, average number of infusions administered as per prescription records and clearance levels in blood samples before and after drug administration."

Answered by AI

Are there any available spots in this research investigation for participants?

"As per the clinicaltrials.gov portal, this trial is not currently enrolling patients as of October 11th 2022. Initially posted on March 14th 2019 and last updated at that same date, there are 3,054 other trials actively recruiting right now."

Answered by AI
~15 spots leftby Mar 2025