IGHTBEAM-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.
- Conditions
- Hematologic Malignancies or Solid Tumors in Pediatric and Young AdultsMedDRA version: 21.0Level: LLTClassification code: 10049280Term: Solid tumour Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10066481Term: Hematological malignancy Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507178-41-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 112
Advanced/relapsed/refractory disease that is incurable and for which prior therapy was unsuccessful or for which standard therapy with known clinical benefit is unavailable/inappropriate., For hematological malignancies: Confirmed diagnosis of B-precursor B-cell acute lymphoblastic leukemia (ALL) or diffuse large B-cell lymphoma (DLBCL)/Burkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues in second or greater relapse which is refractory to or for which further standard therapy is not available and who have exhausted all therapies of known clinical benefit., For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma which is refractory to frontline therapy and for which further standard therapy is not available/inappropriate or in first or greater relapse; Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions; Measurable disease for individuals with neuroblastoma should follow RECIST 1.1 rules for size and reproducibility and demonstrate positive uptake with either meta-iodo-benzyl-guanidine (MIBG) or fluorodeoxyglucose (FDG). Individuals with neuroblastoma who do not have measurable disease per RECIST 1.1, but have MIBG-avid evaluable disease, may be enrolled.
History of solid organ transplant., 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., 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method