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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 60 months for reporting.

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 more

Secondary 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 more

Awards & 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

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

4,015 Previous Clinical Trials

5,186,243 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,889 Previous Clinical Trials

8,089,103 Total Patients Enrolled

~60 spots leftby Mar 2029

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