jRCT2031250824尚未招募不适用
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
未提供0 个研究点目标入组 3 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 0age 6month old over 至 25age old under（—）
- 性别
- All
入选标准
- •For hematological malignancies: Confirmed diagnosis of B-precursor B-cell acute lymphoblastic leukemia (B-ALL) or Diffuse large B-cell lymphoma(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.
排除标准
- •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.
研究者
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