NCT06488716终止1 期
A Phase Ia/Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 11
- 主要终点
- Number of Participants iwth Dose Limiting Toxicity (DLTs)
研究概览
简要总结
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.
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
- •Life expectancy at least 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate hematologic and end-organ function
- •Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
- •Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
- •Availability of representative tumor specimens required for patients in select cohorts.
排除标准
- •Women who are pregnant or breastfeeding
- •Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
- •Active hepatitis B or C or tuberculosis
- •Positive test for human immunodeficiency virus (HIV) infection
- •Acute or chronic active Epstein-Barr virus (EBV) infection at screening
- •Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7759065 infusion
- •Primary, untreated, or active central nervous system (CNS) metastases
- •Active or history of autoimmune disease or immune deficiency
- •Prior allogeneic stem cell or organ transplantation
- •Any history of a Grade 3 immune-mediated adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of that agent
- •Any history of a Grade 4 immune-mediated adverse event attributed to prior cancer immunotherapy.
研究组 & 干预措施
Phase Ia: Dose Escalation
Experimental
干预措施: RO7759065 (Drug)
Phase Ia: Expansion
Experimental
干预措施: RO7759065 (Drug)
Phase Ib: Dose Escalation
Experimental
干预措施: RO7759065 (Drug)
Phase Ib: Dose Escalation
Experimental
干预措施: Atezolizumab (Drug)
Phase Ib: Expansion
Experimental
干预措施: RO7759065 (Drug)
Phase Ib: Expansion
Experimental
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Number of Participants iwth Dose Limiting Toxicity (DLTs)
时间窗: Up to approximately 5 years
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 5 years
次要结局
- Objective Response Rate (ORR)(Up to Approximately 5 Years)
- Duration of Response (DOR)(Up to approximately 5 years)
- Maximum Serum Concentration (Cmax) of RO7759065(Up to approximately 5 years)
- Progression Free Survival (PFS)(Up to approximately 5 years)
- Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7759065(Up to approximately 5 years)
研究者
研究点 (11)
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