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 - GO44096

F. Hoffmann-La Roche AG0 个研究点目标入组 63 人开始时间: 2024年1月16日最近更新: 2024年8月21日

适应症

试验速览

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•Histologic documentation of locally advanced, recurrent, or metastataic 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., Adequate hematologic and end organ function, PD-L1-selected tumors, as determined by the investigational VENTANA® PD-L1 (SP263) IHC assay. Tumor types include: EAC, ESCC, GC, GEJ, HCC, melanoma, NSCLC, RCC, SCCHN, and UBC., Measurable disease per RECIST v1.1, Life expectancy =12 weeks

•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, Prior treatment with CPIs including but not limited to anti-TIGIT, anti-PD-L1, anti-PD-1, anti-CTLA-4, Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control), Malignancies other than disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ), Acute infection and/or treatment with systemic antibiotics within 4 weeks of first dose, 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

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