LIGHTBEAM-U01 Substudy 01C: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 26
- 主要终点
- Part 1: Ctrough of DXd in plasma
研究概览
简要总结
- Part 1: To evaluate the safety and tolerability and to establish a preliminary RP2D of patritumab deruxtecan (HER3-DXd)
- Part 1: To characterize the PK of HER3-DXd
- Part 1 and Part 2: To evaluate the preliminary antitumor effect of HER3-DXd in terms of ORR according to RECIST 1.1 per investigator assessment by tumor type
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Has one of the following histologically confirmed advanced or metastatic solid tumors: Rhabdomyosarcoma (RMS), or Hepatoblastoma
- •Has progressed after at least 1 prior systemic treatment for RMS or hepatoblastoma and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens)
- •Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have Grade ≤2 neuropathy are eligible
- •Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
- •Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
排除标准
- •Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis that cannot be ruled out by standard diagnostic assessments
- •Has a known additional malignancy that is progressing or has required active treatment within the past 1 year
- •Has an active infection requiring systemic therapy
- •Has concurrent active hepatitis B (HBsAg positive and/or detectable HBV deoxyribonucleic acid [DNA]) and HCV defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid [RNA]) infection
- •Has not adequately recovered from major surgery or have ongoing surgical complications
- •Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness
- •Has a history of solid organ transplant
- •Has a history of allogeneic stem cell transplant
- •Has clinically significant corneal disease
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis/leptomeningeal disease; participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks
- •Has uncontrolled or significant cardiovascular disorder
- •Has a history of clinically significant congenital cardiac syndrome
- •Has a history of human immunodeficiency virus (HIV) infection
研究组 & 干预措施
-
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Part 1: Ctrough of DXd in plasma
Part 1: Ctrough of DXd in plasma
Part 1 and Part 2: Objective Response Rate (ORR)
Part 1 and Part 2: Objective Response Rate (ORR)
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Part 1: Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Part 1: Percentage of Participants Who Experience an Adverse Event (AE)
Part 1: Percentage of Participants Who Experience an Adverse Event (AE)
Part 1: Percentage of Participants Who Discontinue Study Treatment Due to an AE
Part 1: Percentage of Participants Who Discontinue Study Treatment Due to an AE
Part 1: Area Under the Curve (AUC) of total anti-HER3 antibody liquid chromatography-mass spectrometry (LC-MS) in plasma
Part 1: Area Under the Curve (AUC) of total anti-HER3 antibody liquid chromatography-mass spectrometry (LC-MS) in plasma
Part 1: AUC of anti-HER3 antibody-conjugated DXd (anti-HER3-ac-DXd) in plasma
Part 1: AUC of anti-HER3 antibody-conjugated DXd (anti-HER3-ac-DXd) in plasma
Part 1: AUC of DXd in plasma
Part 1: AUC of DXd in plasma
Part 1: Maximum Concentration (Cmax) of anti-HER3 antibody LC-MS in plasma
Part 1: Maximum Concentration (Cmax) of anti-HER3 antibody LC-MS in plasma
Part 1: Cmax of anti-HER3-ac-DXd in plasma
Part 1: Cmax of anti-HER3-ac-DXd in plasma
Part 1: Cmax of DXd in plasma
Part 1: Cmax of DXd in plasma
Part 1: Concentration Immediately Before the Next Dose is Administered (Ctrough) of anti-HER3 antibody LC-MS in plasma
Part 1: Concentration Immediately Before the Next Dose is Administered (Ctrough) of anti-HER3 antibody LC-MS in plasma
Part 1: Ctrough of anti-HER3-ac-DXd
Part 1: Ctrough of anti-HER3-ac-DXd
次要结局
- Part 2: Percentage of Participants Who Experience an AE
- Part 2: Percentage of Participants Who Discontinue Study Treatment Due to an AE
- Part 1 and Part 2: Disease Control Rate (DCR)
- Part 1 and Part 2: Time to Response (TTR)
- Part 1 and Part 2: Duration of Response (DOR)
- Part 1 and Part 2: Progressive-free Survival (PFS)
- Part 1 and Part 2: Overall Survival (OS)
- Part 2: AUC of total anti-HER3 antibody LC-MS in plasma
- Part 2: AUC of anti-HER3-ac-DXd in plasma
- Part 2: AUC of DXd in plasma
- Part 2: Cmax of anti-HER3 antibody LC-MS in plasma
- Part 2: Cmax of anti-HER3-ac-DXd in plasma
- Part 2: Cmax of DXd in plasma
- Part 2: Ctrough of anti-HER3 antibody LC-MS in plasma
- Part 2: Ctrough of anti-HER3-ac-DXd in plasma
- Part 2: Ctrough of DXd in plasma
研究者
Sama Ahsan
Scientific
Merck Sharp & Dohme LLC