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

Hoffmann-La Roche51 个研究点分布在 9 个国家目标入组 64 人2023年5月4日

适应症PD-L1-selected Solid Tumors

干预措施Tiragolumab and Atezolizumab IV FDC

相关药物Tiragolumab and Atezolizumab IV FDC

概览

阶段: 2 期
干预措施: Tiragolumab and Atezolizumab IV FDC
疾病 / 适应症: PD-L1-selected Solid Tumors
发起方: Hoffmann-La Roche
入组人数: 64
试验地点: 51
主要终点: Percentage of Participants With Adverse Events (AEs)
状态: 已完成
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2023年5月4日

结束日期

2025年12月26日

最后更新

2个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Hoffmann-La Roche

责任方

Sponsor

入排标准

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)

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

研究组 & 干预措施

Tiragolumab and Atezolizumab IV FDC

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

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))