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NCT06395103 | Not yet recruiting | B-cell Acute Lymphoblastic Leukemia

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

Merck Sharp & Dohme LLC

Brief Summary:

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.

Condition or disease

B-cell Acute Lymphoblastic Leukemia

Diffuse Large B-cell Lymphoma

Burkitt Lymphoma

Neuroblastoma

Ewing Sarcoma

Intervention/treatment

Zilovertamab vedotin

Phase

Phase 1

Phase 2

Study Type : Interventional
Estimated Enrollment : 90 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : LIGHTBEAM-U01 Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors
Actual Study Start Date : June 4, 2024
Estimated Primary Completion Date : March 31, 2029
Estimated Study Completion Date : March 31, 2029
Arm Intervention/treatment

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).

Biological: Zilovertamab vedotin
Ages Eligible for Study: 6 Months to 25 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)

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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)

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