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RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Months to 25 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well zilovertamab vedotin works and how safe it is. It is for children with certain blood cancers or neuroblastoma whose cancer has come back or has not responded to treatment. It also includes children and young adults with Ewing sarcoma.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of B-cell acute lymphoblastic leukemia (B-ALL), a blood cancer, or diffuse large B-cell lymphoma (DLBCL) or Burkitt lymphoma, cancers of the immune system.
  • Or have neuroblastoma or Ewing sarcoma confirmed by a tissue test. These are cancers that form solid tumors.

Who can't join

  • Have had an organ transplant, or have graft-versus-host disease, where donated cells attack the body, or take medicines to treat or prevent it.
  • Have serious active heart or blood vessel disease, liver scarring called cirrhosis, or Down syndrome.
  • Have more than mild nerve damage, or a form of Charcot-Marie-Tooth disease that damages the covering of nerves.
  • Have a history of HIV or hepatitis B, active hepatitis C, or an active infection needing medicine that works throughout the body.
  • Cannot safely receive a study drug ingredient, including because of an allergy, or take certain medicines that affect how the body handles drugs.
  • Have had recent radiation, cancer treatment, an experimental drug or device, or a live vaccine. Waiting periods and some exceptions apply.
  • Take long-term steroids above a dose equal to 10 mg of prednisone daily. Steroid doses must also have been stable for at least 4 weeks before treatment starts.
  • Have another cancer that is growing or needed treatment in the past year, have not recovered enough from major surgery or radiation, or still have surgery-related problems.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (17)

CA

CO

  • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016) · Aurora, CO 80045Study Coordinator · Study contact · 720-777-1234More trials in Aurora

CT

FL

IA

MA

MI

MO

ND

NJ

NY

OR

PA

SD

TX

UT