A Phase Ia/Ib, Open-Label, Multicenter, Global, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XmAb24306 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 45
- 主要终点
- Percentage of Participants with Adverse Events
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 alone or in combination with a checkpoint inhibitor treatment in participants with locally advanced or metastatic solid tumors.
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
- •Key General Inclusion Criteria
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Life expectancy >/= 12 weeks
- •Adequate hematologic and end-organ function
- •For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
- •Negative serum pregnancy test for women of childbearing potential
- •Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •Availability of representative tumor specimens
- •Key General
排除标准
- •Pregnant or breastfeeding, or intending to become pregnant during the study
- •Significant cardiovascular disease
- •Current treatment with medications that prolong the QT interval
- •Known clinically significant liver disease
- •Poorly controlled Type 2 diabetes mellitus
- •Symptomatic, untreated, or actively progressing CNS metastases
- •History of leptomeningeal disease
- •History of malignancy other than disease under study within 3 years prior to screening
- •Active or history of autoimmune disease or immune deficiency
- •Active tuberculosis, hepatitis B, hepatitis C, or known/suspected Epstein Barr virus infection
- •Positive for HIV infection
- •Prior allogeneic stem cell or solid organ transplantation
研究组 & 干预措施
Phase 1a Dose Expansion
Participants will receive XmAb24306 until study treatment discontinuation or study termination.
干预措施: XmAb24306 (Drug)
Phase 1a Dose Escalation
Participants will receive XmAb24306 until study treatment discontinuation or study termination.
干预措施: XmAb24306 (Drug)
Phase 1b Dose Escalation
Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
干预措施: XmAb24306 (Drug)
Phase 1b Dose Escalation
Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
干预措施: Atezolizumab (Drug)
Phase 1b Dose Expansion
Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
干预措施: Atezolizumab (Drug)
Phase 1b Dose Expansion
Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.
干预措施: XmAb24306 (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events
时间窗: Up to approximately 4 years
次要结局
- Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1(Up to approximately 4 years)
- Serum Concentration of XmAb24306(Baseline, then at pre-defined intervals for the first year of treatment or until participant discontinues study treatment)
- Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1(Up to approximately 4 years)
- Overall Survival (OS)(Up to approximately 4 years)
- Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(Up to approximately 4 years)
- ORR as Based on Radiographic Assessment by the Investigator Using Modified RECIST v1.1 for Immune-Based Therapeutics (iRECIST)(Up to approximately 4 years)
- DOR as Based on Radiographic Assessment by the Investigator Using iRECIST(Up to approximately 4 years)
- PFS as Based on Radiographic Assessment by the Investigator Using iRECIST(Up to approximately 4 years)