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Antibody-drug conjugate
Zilovertamab vedotin for Chronic Lymphocytic Leukemia
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
Be older than 18 years old
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3.5 years
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 moreTrial 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
Langdon L Miller, MDStudy DirectorVelosBio Inc.
1 Previous Clinical Trials
102 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a type of blood cancer that has been treated in the past but has gotten worse or come back after treatment.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.You have had a serious heart condition in the last 3 months before starting the study treatment.You have already received treatment with a specific type of medication called a ROR1-directed therapy.You have taken a medication within the past week that can make your heart rhythm abnormal.You are eligible for a special type of treatment called hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor (CAR)-T-cell therapy. You have access to these treatments and are willing to undergo them.You have another type of cancer that could make it unsafe or difficult to participate in the study, or could affect how the study results are interpreted.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.You have been treated with a medication that contains MMAE before, and that's okay.
Research Study Groups:
This trial has the following groups:- Group 1: Zilovertamab vedotin Schedule 3: Q3/4W
- Group 2: Zilovertamab vedotin Schedule 1: Q1/3W
- Group 3: Zilovertamab vedotin Schedule 2: Q2/3W
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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