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

NCT06395103

RecruitingPhase 1, Phase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma, Burkitt Lymphoma, Neuroblastoma, Ewing Sarcoma

Interventions: Zilovertamab vedotin

Countries: United States, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czechia

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.

Eligibility overview

Sex: ALL

Age: 6 Months to 25 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (71)
  • Los Angeles, California, United States
  • Aurora, Colorado, United States
  • New Haven, Connecticut, United States
  • St. Petersburg, Florida, United States
  • Iowa City, Iowa, United States
  • Boston, Massachusetts, United States
  • Grand Rapids, Michigan, United States
  • Kansas City, Missouri, United States
  • New Brunswick, New Jersey, United States
  • New York, New York, United States
  • Valhalla, New York, United States
  • Fargo, North Dakota, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Sioux Falls, South Dakota, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Randwick, New South Wales, Australia
  • Brisbane, Queensland, Australia
  • Melbourne, Victoria, Australia
  • Ghent, Oost-Vlaanderen, Belgium
  • Curitiba, Paraná, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Barretos, São Paulo, Brazil
  • São José do Rio Preto, São Paulo, Brazil
  • Calgary, Alberta, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Concepción, Biobio, Chile
  • Santiago, Region M. de Santiago, Chile
  • + 41 more on CT.gov