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Phase I-II

A Phase 1/2 Platform Study to Evaluate the Safety and Efficacy of Investigational Agents in Pediatric and Young Adult Participants with Hematologic Malignancies or Solid Tumors

  • Study HIC#:2000036967
  • Last Updated:11/07/2024

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 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.

    Contact Us

    For more information about this study, including how to volunteer, contact:

    Jaime Rotatori

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    You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.

    Eligibility 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.