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/ RecruitingEarly Phase 1IIT An Open-label, Single-center Study to Evaluate the Dose Escalation and Cohort Expansion of YSCH-01 in Subjects With Pulmonary Metastasis of Advanced Solid Tumors and Advanced Non-small Cell Lung Cancer by Nebulized Inhalation Administration
This is an open-label, dose-escalation and cohort expansion study to evaluate the safety and preliminary efficacy of YSCH-01 in subjects with pulmonary metastasis of advanced solid tumors and advanced non-small cell lung cancer by nebulized inhalation administration. This study is consisting of two phases: the dose escalation phase and the cohort expansion phase.
/ RecruitingEarly Phase 1IIT An Open-Label, Single-Center, Multiple-Dose Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of YSCH-01 Monotherapy and in Combination With Atezolizumab in the Treatment of Recurrent Glioblastoma
The clinical study of YSCH-01 will adopt an open-label, randomized design, with a planned enrollment of 10 participants with recurrent glioblastoma. Participants will be randomly allocated to the YSCH-01 monotherapy cohort or the YSCH-01 + Atezolizumab combination cohort, with 5 participants in each cohort. The study consists of the following three phases: screening phase, treatment phase, and follow-up phase. The primary endpoint is the 1-year survival rate of participants
一项在晚期实体瘤受试者中评估YSCH-01瘤内注射的安全性/耐受性和初步疗效的开放、单/多次给药剂量递增及剂量扩展临床研究
[Translation] An open-label, single/multiple-dose dose-escalation and dose-expansion clinical study to evaluate the safety/tolerability and preliminary efficacy of intratumoral injection of YSCH-01 in subjects with advanced solid tumors
主要目的
评价YSCH-01用于治疗复发/难治性晚期实体瘤受试者的安全性/耐受性。
确定YSCH-01临床推荐剂量。
次要目的
评价YSCH-01治疗复发/难治性晚期实体瘤的初步疗效。
评估YSCH-01的生物分布和病毒脱落情况。
评价接受YSCH-01受试者体内的药效学(PD)。
评价接受YSCH-01受试者体内的免疫原性。
初步评估YSCH-01对复发/难治性晚期实体瘤受试者生活质量的影响。
[Translation] Primary Objectives
Evaluate the safety/tolerability of YSCH-01 for the treatment of subjects with relapsed/refractory advanced solid tumors.
Determine the recommended clinical dose of YSCH-01.
Secondary Objectives
Evaluate the preliminary efficacy of YSCH-01 in the treatment of relapsed/refractory advanced solid tumors.
Evaluate the biodistribution and viral shedding of YSCH-01.
Evaluate the pharmacodynamics (PD) in subjects receiving YSCH-01.
Evaluate the immunogenicity in subjects receiving YSCH-01.
Preliminary evaluation of the effect of YSCH-01 on the quality of life of subjects with relapsed/refractory advanced solid tumors.
100 Clinical Results associated with Shanghai Yuan Song Biotechnology Co., Ltd.
0 Patents (Medical) associated with Shanghai Yuan Song Biotechnology Co., Ltd.
100 Deals associated with Shanghai Yuan Song Biotechnology Co., Ltd.
100 Translational Medicine associated with Shanghai Yuan Song Biotechnology Co., Ltd.