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OncoMatch/Clinical Trials/NCT06395103

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

Is NCT06395103 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies Zilovertamab vedotin for b-cell acute lymphoblastic leukemia.

Phase 1/2RecruitingMerck Sharp & Dohme LLCNCT06395103Data as of Jun 2026Location: International · 23 countries

Treatment: Zilovertamab vedotinSubstudy 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 relapsed 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Zilovertamab vedotin

Cancer type

Acute Lymphoblastic Leukemia

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Neuroblastoma

Sarcoma

Demographics

Ages 0–25

Prior therapy

Cannot have received: radiation therapy

Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.

Cannot have received: systemic anticancer therapy

Exception: except for prophylactic intrathecal chemotherapy and/or cytoreductive therapy with steroids/hydroxyurea

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).

Cannot have received: investigational agent

Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Children's Hospital Los Angeles ( Site 1006) · Los Angeles, California
  • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016) · Aurora, Colorado
  • Yale New Haven Hospital ( Site 1012) · New Haven, Connecticut
  • Johns Hopkins All Children's Hospital ( Site 1025) · St. Petersburg, Florida
  • University of Iowa-Holden Comprehensive Cancer Center ( Site 1017) · Iowa City, Iowa

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06395103 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior radiation therapy, systemic anticancer therapy, investigational agent disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 25 years or younger and at least 0 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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