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Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)

Study Purpose

Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with elapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)/Burkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with Ewing sarcoma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 6 Months - 25 Years
Gender All
More Inclusion & Exclusion Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

  • - For hematological malignancies: 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 solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma.

Exclusion Criteria:

  • - History of solid organ transplant.
  • - Clinically significant (ie, active) cardiovascular disease.
  • - Known history of liver cirrhosis.
  • - Ongoing Grade >1 peripheral neuropathy.
  • - Demyelinating form of Charcot-Marie-Tooth disease.
  • - Diagnosed with Down syndrome.
  • - Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.
  • - History of human immunodeficiency virus (HIV) infection.
  • - Contraindication or hypersensitivity to any of the study intervention components.
  • - Received prior radiotherapy within 4 weeks of start of study intervention.
Participants must have recovered from all radiation-related toxicities.
  • - Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent).
Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1).
  • - Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention.
  • - Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention (except for prophylactic intrathecal chemotherapy and/or cytoreductive therapy with steroids/hydroxyurea.
  • - Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Administration of killed vaccines is allowed.
  • - Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
  • - Known additional malignancy that is progressing or has required active treatment within the past 1 year.
  • - Active infection requiring systemic therapy.
  • - Known history of Hepatitis B or known active Hepatitis C virus infection.
  • - Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06395103
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Merck Sharp & Dohme LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Medical Director
Principal Investigator Affiliation Merck Sharp & Dohme LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma, Burkitt Lymphoma, Neuroblastoma, Ewing Sarcoma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Zilovertamab vedotin

Participants receive escalating doses of zilovertamab vedotin via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks).

Interventions

Biological: - Zilovertamab vedotin

Administered via IV infusion

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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