NCT07773454尚未招募1 期
A Phase 1 Dose-Escalation Study of XL092 in Children and Adolescents With Relapsed or Refractory Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Exelixis
- 入组人数
- 18
- 主要终点
- Number of Participants With Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
The primary purpose of this study is to determine the pediatric maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and to evaluate the safety and tolerability of zanzalintinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be < 17 years old.
- •Participants must have a minimum body weight of ≥ 10 kilograms (kg) at enrollment.
- •Performance status of ≥ 50% as measured by Lansky for participants < 16 years of age or Karnofsky for participants ≥ 16 years of age.
- •Have a relapsed or refractory solid tumor, including primary CNS tumors (excluding lymphoma).
排除标准
- •For participants with CNS primary tumors, evidence of intracranial or intratumoral hemorrhage are excluded.
- •Diagnosis of lymphoma.
- •Lesions invading major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Number of Participants With Dose-Limiting Toxicities (DLTs)
时间窗: Up to Day 28
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to 8 months
次要结局
- Maximum Plasma Concentration (Cmax) of Zanzalintinib(From Week 1 Day 1 to Week 21 Day 1)
- Time to Maximum Plasma Concentration (Tmax) of Zanzalintinib(From Week 1 Day 1 to Week 21 Day 1)
- Area Under the Concentration-Time Curve (AUC) of Zanzalintinib(From Week 1 Day 1 to Week 21 Day 1)
研究者
相似试验
招募中
2 期
A clinical study to evaluate the safety, tolerability and early efficacy of the study drug (Durvalumab) alone and a combination of study drugs (Durvalumab and Tremelimumab) in children with advanced solid tumours and blood cancer2023-510424-68-00AstraZeneca AB11
招募中
1 期
Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid TumorsProstate CancerOvarian CancerGastric CancerNCT07517198Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.40
尚未招募
1 期
CIB In Vivo CAR-T Lentiviral Injection in Patients With Advanced Malignant TumorsNCT07657585Cancer Institute and Hospital, Chinese Academy of Medical Sciences91
招募中
1 期
CD64 CAR T Cell Therapy in Adults With Relapsed and/or Refractory AMLMyelodysplastic SyndromeNCT07347418University of Colorado, Denver23
招募中
1 期
Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 MutationSolid Tumors (Phase 1)NCT07561554Haisco Pharmaceutical Group Co., Ltd.159