An Open-Label, Multicenter Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of RO7616789 in Participants With Advanced Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

Yoh Kiyotaka0 个研究点目标入组 168 人开始时间: 2022年12月14日最近更新: 2023年10月17日

试验速览

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•Life expectancy at least 12 weeks
•-Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
•-Adequate hematologic and end organ function
•-Negative serum pregnancy test.
•-Adequate contraception and no or interruption of breastfeeding
•-Histologically confirmed extensive SCLC or high grade NEC of any other origin that have relapsed after at least 1 systemic therapy and for which standard therapy has proven to be i-neffective or intolerable or is considered inappropriate.
•-Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
•-Confirmed availability of representative archival tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or unstained slides

•-History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti-tumor treatment, or leptomeningeal disease and current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
•-Active or history of clinically significant autoimmune disease
•-Positive test for human immunodeficiency virus (HIV) infection
•-Active hepatitis B or hepatitis C
•-Prior treatment with anti-cluster of differentiation (CD)137 agents, anti-CD3 agents and/or delta-like ligand 3 (DLL3) targeted therapies
•-Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 21 days prior to initiation of study treatment
•-Any history of an immune-related Grade 4 adverse event (AE) attributed to prior anti-programmed death ligand-1 (PD-L1) /PD-1 or anti-cytotoxic T-lymphocyte-associated protein (CTLA-4) therapy (other than asymptomatic elevation of serum amylase or lipase)
•-Any history of an immune-related Grade 3 adverse event attributed to prior anti-PD-L1 /PD-1 or anti-CTLA-4 therapy (other than asymptomatic elevation of serum amylase or lipase) that resulted in permanent discontinuation of the prior immunotherapeutic agent
•-Administration of a live, attenuated vaccine within 4 weeks before first RO7616789 infusion

发起方

Yoh Kiyotaka