NCT06372574招募中1 期
A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7617991 in HLA-A*02-Positive Patients With Locally Advanced and/or Metastatic MAGE-A4-Positive Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 210
- 主要终点
- Incidence and Severity of Adverse Events
研究概览
简要总结
This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 or 1
- •Body weight ≥40 kilograms
- •Life expectancy of at least 12 weeks
- •Confirmed eligible HLA-A*02 genotype and tumor with confirmed MAGE-A4 expression
- •Histologically confirmed locally advanced or metastatic solid tumor malignancy that has relapsed or is refractory to established therapies
- •Measurable disease, according to RECIST v1.1
- •Adequate hematologic and end-organ function
- •Resolution to Grade ≤2 of all acute, clinically significant treatment-related toxicity from prior therapy
- •An archival tumor tissue specimen or fresh baseline biopsy (when archival is not available) is required
排除标准
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of RO7617991 or tocilizumab
- •Clinically significant cardiopulmonary dysfunction
- •Clinically significant liver disease
- •Poorly controlled Type 2 diabetes mellitus
- •Active hepatitis B or C infection
- •Positive test for human immunodeficiency virus (HIV)
- •History of allergic reactions to red meat or tick bites or known galactose-alpha-1,3-galactose (alpha-gal) hypersensitivity
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •Symptomatic pleural effusion, pericardial effusion, or ascites or any prior procedural intervention for pleural effusion, pericardial effusion, or ascites within 6 weeks prior to enrollment
- •Active or history of autoimmune disease or immune deficiency
- •Treatment with systemic immunosuppressive medications
- •Prior allogeneic stem cell or solid organ transplantation
研究组 & 干预措施
RO7617991 Dose Escalation and Expansion
Experimental
干预措施: RO7617991 (Drug)
RO7617991 Dose Escalation and Expansion
Experimental
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events
时间窗: From first dose until 90 days after the final dose of study treatment (up to approximately 3 years)
Number of Participants with Abnormal Values in Clinical Laboratory Test Parameters
时间窗: From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)
Number of Participants with Abnormal Values in Targeted Vital Signs
时间窗: From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)
The targeted vital signs include pulse rate, respiratory rate, systolic and diastolic blood pressure, pulse oximetry, and body temperature.
次要结局
- Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1(From enrollment to the first occurrence of disease progression or relapse or death, whichever occurs first (up to approximately 3 years))
- Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1(From first occurrence of a confirmed objective response to disease progression or death, whichever occurs first (up to approximately 3 years))
- Prevalence of Anti-Drug Antibodies (ADAs) to RO7617991 at Baseline and Incidence of ADAs to RO7617991 During the Study(Baseline (predose) and from first dose until 90 days after the final dose of study treatment (up to approximately 3 years))
- Overall Survival (OS)(From enrollment to death from any cause (up to approximately 3 years))
- Serum Concentration of RO7617991 at Specific Timepoints(From first dose until 30 days after the final dose of study treatment (up to approximately 3 years))
- Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1(From Baseline until until radiographic disease progression or loss of clinical benefit (up to approximately 3 years))
研究者
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