NCT05661578已完成2 期
A Phase II, Single-Arm, Open-Label Study Evaluating the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 49
- 主要终点
- Percentage of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety, pharmacokinetics, and immunogenicity of tiragolumab and atezolizumab intravenous fixed-dose combination (IV FDC) in participants with histologically confirmed PD-L1-selected solid tumors whose disease is locally advanced, recurrent, or metastatic and for whom an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option.
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
- 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
- •Life expectancy >=12 weeks
- •Adequate hematologic and end organ function
- •Recovery (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia
- •For female participants of childbearing potential, negative serum pregnancy test within 14 days prior to initiation of study treatment (Day 1 of Cycle 1)
- •For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs during the treatment period and for 5 months after the final dose of tiragolumab and atezolizumab IV FDC
- •For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab and atezolizumab IV FDC to avoid exposing the embryo
- •Cancer-Specific Inclusion Criteria:
- •Histologic documentation of locally advanced, recurrent, or metastatic malignancy, ineligible for definitive local therapy, for which a clinical trial of an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option. Participant must be informed of all standard of care options available for his/her cancer.
- •No prior treatment with checkpoint inhibitor therapies (CPI-Naive)
- •Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- •Submittal of archival tumor and/or fresh tumor tissue to the central laboratory for programmed death-1 (PD-L1) evaluation prior to enrollment
- •PD-L1 selected tumors, as determined by the investigational VENTANA PD-L1 (SP263) immunohistochemistry (IHC) assay
排除标准
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of tiragolumab and atezolizumab IV FDC
- •Significant cardiovascular disease
- •Known clinically significant liver disease
- •Poorly controlled Type 2 diabetes mellitus
- •Major surgical procedure within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study
- •Any other diseases, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or may render the participant at high risk from treatment complications
- •History of autoimmune disease
- •Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
- •History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •Severe infections within 4 weeks prior to Day 1 of Cycle 1 or recent infections/oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
- •Cancer-Specific Exclusion Criteria:
- •Any anti-cancer therapy, whether investigational or approved within 3 weeks prior to initiation of study treatment
- •Prior treatment with immune checkpoint inhibitors (CPIs)
- •Less than 5 drug-elimination half-lives (~100 days for typical monoclonal antibody [Mab]) from the last dose of monoclonal antibodies (MAbs), and MAb-Derived Therapies (excluding CPIs) and the proposed Day 1 of Cycle 1
- •Less than 6 weeks between the last dose of prior immunomodulators and the proposed Day 1 of Cycle 1
- •Less than 6 weeks or 5-drug-elimination half-lives, whichever is shorter, of prior treatment with cancer vaccines and/or cytokines have elapsed between the last dose and the proposed Cycle 1, Day 1
- •Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy
- •Any history of an immune-mediated Grade 3 adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of the prior immunotherapeutic agent and/or occurred </=6 months prior to Day 1 of Cycle 1
- •Any immune-mediated adverse events related to prior cancer immunotherapy must have resolved completely to baseline
- •Adverse events from prior anti-cancer therapy that have not resolved to Grade <=1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
研究组 & 干预措施
Tiragolumab and Atezolizumab IV FDC
Experimental
Participants will receive tiragolumab and atezolizumab as an intravenous fixed dose combination (IV FDC) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
干预措施: Tiragolumab and Atezolizumab IV FDC (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)
时间窗: Up to approximately 24 months
次要结局
- Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab(Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12, 16 and treatment discontinuation (TD) visit (up to approximately 24 months))
- Cmax of Atezolizumab(Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15)
- Area Under the Concentration Time Curve (AUC) of Tiragolumab(Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15)
- AUC of Atezolizumab(Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15)
- Maximum Serum Concentration (Cmax) of Tiragolumab(Cycle 1 (each cycle is 21 days): Days 1, 2, 8 and 15)
- Percentage of Participants With ADAs to Atezolizumab(Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12, 16 and TD visit (up to approximately 24 months))
研究者
研究点 (49)
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