A Dose Escalation and Expansion Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Exelixis
- 入组人数
- 150
- 试验地点
- 9
- 主要终点
- Number of Participants with a Dose-limiting Toxicity (DLT)
研究概览
简要总结
The primary purpose of the study is to characterize the safety and tolerability of XB371. The dose-escalation cohorts and Part B of the expansion cohorts are non-randomized. Part A of the expansion cohorts is randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Minimum life expectancy of ≥ 12 weeks.
- •Recurrent locally advanced or metastatic solid tumors.
- •Adequate end organ and bone marrow function.
排除标准
- •Primary brain tumors or known active brain metastases, leptomeningeal, or cranial epidural disease.
- •History of interstitial lung disease (ILD) of any grade or history of organizing pneumonia.
- •Has acute ocular infection, acute or chronic ulcerative/cicatricial condition of conjunctiva or cornea.
- •Known history of immunodeficiency virus (HIV) unless specific criteria are met.
- •Active infection with hepatitis C virus (HCV) defined as positive for HCV antibody.
- •Major surgery within 4 weeks before the first dose of study treatment.
- •Received radiation therapy within 2 weeks before the first dose of study treatment.
- •Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Dose-escalation Cohorts
Participants will receive escalating doses of XB371 every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.
干预措施: XB371 (Drug)
Dose-expansion Cohorts: Part A
Participants with Tumor Type 1 (tumor type will be selected based on available data) will be randomized to receive XB371 at one of two recommended dose levels (recommended dose [RD]-1 or RD-2) every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.
干预措施: XB371 (Drug)
Dose-expansion Cohorts: Part B
Participants with Tumor Type 2 (tumor type will be selected based on available data) will receive XB371 at the recommended dose level every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.
干预措施: XB371 (Drug)
结局指标
主要结局
Number of Participants with a Dose-limiting Toxicity (DLT)
时间窗: Up to the end of the first cycle (Up to Day 21 of a 21-day cycle)
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
时间窗: Up to approximately 7 months
次要结局
- Area Under the Plasma Concentration-time Curve (AUC) of XB371, Total Antibody and Unconjugated Belotecan(Up to approximately 7 months)
- Maximum Observed Plasma Concentration (Cmax) of XB371, Total Antibody and Unconjugated Belotecan(Up to approximately 7 months)
- Time to Maximum Observed Plasma Concentration (Tmax) of XB371, Total Antibody and Unconjugated Belotecan(Up to approximately 7 months)
- Dose-expansion Cohorts Only: Objective Response Rate as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)(Up to approximately 18 months)
- Dose-expansion Cohorts Only: Duration of Response as Assessed by the Investigator per RECIST v1.1(Up to approximately 18 months)
- Trough Observed Plasma Concentration (Ctrough) of XB371, Total Antibody and Unconjugated Belotecan(Up to approximately 7 months)
- Number of Participants with Antidrug Antibodies to XB371(Up to approximately 7 months)
- Dose-escalation Cohorts Only: Recommended Dose(s) for Expansion(Through completion of dose-escalation (up to approximately 18 months))