An open label, Phase I study of BI 765063 monotherapy, and its combination therapy with BI 754091, to characterize safety, pharmacokinetics, and pharmacodynamics in Japanese patients with advanced solid tumors

akajima Michiko0 个研究点目标入组 36 人开始时间: 2021年2月9日最近更新: 2023年10月17日

试验速览

暂无简介。

•Patients with the SIRPa V1 allele, i.e. either homozygous V1/V1 or heterozygous V1/V2 individuals
•Patients with histologically or cytologically documented advanced/metastatic primary, or recurrent, solid tumors and whose tumor progressed on or who are not eligible for standard therapy
•Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
•Presence of at least one measurable lesion according to response evaluation criteria in solid tumors (RECIST) 1.1
•Patients who agree to pre- and on-treatment tumor biopsies.

•- Patients without at least one SIRPa V1 allele, i.e. homozygous SIRPa V2/V2 individuals
•- Presence of invasive cancers, other than the one treated in this trial, within 5 years prior to screening
•- HIV, HBV, or HCV infection
•- Active, known or suspected, autoimmune disease
•- Patients who have interstitial lung disease or active non-infectious pneumonitis
•- Serious concomitant disease or medical or psychiatric condition affecting compliance with trial requirements
•- Patients with symptomatic/active brain metastases

发起方

akajima Michiko