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Antibody-drug Conjugate
Zilovertamab Vedotin for Pediatric and Young Adult Cancers
Phase 1 & 2
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of B-precursor B-ALL or DLBCL/Burkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues for hematological malignancies
Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma for solid tumor malignancies
Must not have
History of solid organ transplant
Clinically significant (ie, active) cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 60 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing a new drug called zilovertamab vedotin in children and young adults with certain types of cancer to see if it is effective and safe."
Who is the study for?
This trial is for young people with certain blood cancers or solid tumors, like B-cell acute lymphoblastic leukemia, Burkitt lymphoma, diffuse large B-cell lymphoma, neuroblastoma, and Ewing sarcoma. Participants must have tried other treatments that didn't work (relapsed) or didn't respond to previous treatments (refractory).
What is being tested?
The study tests zilovertamab vedotin's effectiveness and safety in children and young adults. It's a targeted therapy aimed at treating specific types of cancer by delivering a toxin directly to the cancer cells.
What are the potential side effects?
While not specified here, side effects of similar targeted therapies can include fatigue, allergic reactions to the drug infusion, lowered blood cell counts increasing infection risk, nausea or vomiting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of blood cancer.
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My cancer is either neuroblastoma or Ewing sarcoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a solid organ transplant.
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I have an active heart condition.
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I have been diagnosed with a demyelinating form of Charcot-Marie-Tooth disease.
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I haven't had cancer treatment or experimental drugs in the last 4 weeks.
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I have a known history of liver cirrhosis.
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I have been diagnosed with Down syndrome.
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I have ongoing nerve pain or tingling that is not mild.
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I am currently experiencing or being treated for graft-versus-host disease.
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I haven't taken strong CYP3A4 affecting drugs recently or won't need them during the study.
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I have another cancer that has not progressed or needed treatment in the last year.
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I am currently on medication for an infection.
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I have a history of Hepatitis B or an active Hepatitis C infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 60 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing Sarcoma
Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs
+3 moreSecondary study objectives
Part 1 and Part 2: AUC of Antibody-Drug Conjugate (ADC)
Part 1 and Part 2: AUC of Monomethyl Auristatin E (MMAE)
Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Total Antibody
+17 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Zilovertamab vedotinExperimental Treatment1 Intervention
Participants receive escalating doses of zilovertamab vedotin via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zilovertamab vedotin
2019
Completed Phase 1
~100
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,031 Previous Clinical Trials
5,189,614 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,090,895 Total Patients Enrolled