2023-507178-41-00招募中1/2 期
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.
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 26
- 主要终点
- Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT)
研究概览
简要总结
- Part 1: To evaluate the safety and tolerability of zilovertamab vedotin monotherapy in participants from 1 to <18 years of age
- Part 1 and Part 2: To evaluate preliminary antitumor activity of zilovertamab vedotin monotherapy per investigator assessment in participants from birth to <18 years of age for B-ALL, DLBCL/Burkitt lymphoma, and neuroblastoma, and from birth to 25 years for Ewing sarcoma
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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 (As of protocol Amendment 4, in countries in the European Economic Area [EEA], the substudy will not enroll participants with hematological malignancies)
- •For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma (As of protocol Amendment 4, in countries in the European Economic Area [EEA], the substudy will only enroll participants with diagnosis of Ewing sarcoma)
排除标准
- •Has history of solid organ transplant.
- •Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.
- •Has 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).
- •Has 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
- •Has 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.
- •Has 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.
- •Has known additional malignancy that is progressing or has required active treatment within the past 1 year.
- •Has active infection requiring systemic therapy.
- •Has 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.
- •Has clinically significant (ie, active) cardiovascular disease.
- •Known history of liver cirrhosis.
- •Has ongoing Grade >1 peripheral neuropathy.
- •Has demyelinating form of Charcot-Marie-Tooth disease.
- •Has been diagnosed with Down syndrome.
- •Has ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.
- •Has history of human immunodeficiency virus (HIV) infection.
- •Has contraindication or hypersensitivity to any of the study intervention components.
结局指标
主要结局
Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT)
Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT)
Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs)
Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs)
Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs
Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs
Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs
Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs
Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing Sarcoma
Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing Sarcoma
次要结局
- Part 1 and Part 2: Area Under the Curve (AUC) of Total Antibody
- Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of Total Antibody
- Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Total Antibody
- Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Total Antibody
- Part 1 and Part 2: AUC of Antibody-Drug Conjugate (ADC)
- Part 1 and Part 2: Cmax of Antibody-Drug Conjugate (ADC)
- Part 1 and Part 2: Ctrough of Antibody-Drug Conjugate (ADC)
- Part 1 and Part 2: t1/2 of Antibody-Drug Conjugate (ADC)
- Part 1 and Part 2: AUC of Monomethyl Auristatin E (MMAE)
- Part 1 and Part 2: Cmax of Monomethyl Auristatin E (MMAE)
- Part 1 and Part 2: Ctrough of Monomethyl Auristatin E (MMAE)
- Part 1 and Part 2: t1/2 of Monomethyl Auristatin E (MMAE)
- Part 2: Number of Participants Who Experience One or More Adverse Events (AEs)
- Part 2: Number of Participants Who Discontinue Study Treatment Due to AEs
- Part 2: Number of Participants Who Receive Dose Modification Due to AEs
- Part 1 and Part 2: Incidence of Antidrug antibodies (ADAs) to Zilovertamab Vedotin
- Part 1 and Part 2: Duration of Response (DOR)
- Part 1 and Part 2: Percentage of Participants with DLBCL/Burkitt Lymphoma Who Receive Stem Cell Transplant (SCT)
- Part 1 and Part 2: Percentage of Participants with B-ALL Who Receive SCT
- Part 1 and Part 2: Percentage of Participants with B-ALL Who Receive Chimeric Antigen Receptor T (CAR-T)
研究者
Pallavi Pillai
Scientific
Merck Sharp & Dohme LLC
研究点 (26)
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