RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
The main inclusion and exclusion criteria include but are not limited to the following:
Who May Qualify:
- 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: diagnosed by tissue sample (biopsy-confirmed) diagnosis of neuroblastoma or Ewing sarcoma.
Who Should NOT Join This Trial:
- 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 weakened immune system 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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
BIOLOGICAL
Zilovertamab vedotin
Administered via IV infusion
Locations (20)
Children's Hospital Los Angeles ( Site 1006)
Los Angeles, California, United States
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016)
Aurora, Colorado, United States
Yale New Haven Hospital ( Site 1012)
New Haven, Connecticut, United States
Johns Hopkins All Children's Hospital ( Site 1025)
St. Petersburg, Florida, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 1017)
Iowa City, Iowa, United States
Dana-Farber Cancer Institute ( Site 1013)
Boston, Massachusetts, United States
Corewell Health ( Site 1001)
Grand Rapids, Michigan, United States
Children's Mercy Hospital ( Site 1024)
Kansas City, Missouri, United States
Rutgers Cancer Institute of New Jersey ( Site 1008)
New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center ( Site 1010)
New York, New York, United States
New York Medical College ( Site 1023)
Valhalla, New York, United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003)
Fargo, North Dakota, United States
Oregon Health and Science University ( Site 1004)
Portland, Oregon, United States
Children's Hospital of Philadelphia (CHOP) ( Site 1021)
Philadelphia, Pennsylvania, United States
Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015)
Sioux Falls, South Dakota, United States
University of Texas MD Anderson Cancer Center ( Site 1007)
Houston, Texas, United States
Intermountain - Primary Children's Hospital ( Site 1014)
Salt Lake City, Utah, United States
Sydney Children's Hospital ( Site 1997)
Randwick, New South Wales, Australia
Queensland Children's Hospital-Oncology & Haematology ( Site 1996)
Brisbane, Queensland, Australia
UZ Gent ( Site 1428)
Ghent, Oost-Vlaanderen, Belgium