A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SKB518 in Patients With Lung Cancer
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB518 in patients with lung cancer. Eligible subjects will receive SKB518 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females.
• Non-small cell lung cancer (NSCLC) or small cell lung cancer(SCLC) confirmed by histology or cytology.
• At least one measurable tumor lesion per RECIST v1.1.
• Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
• Expected survival period ≥ 12 weeks.
• The function of important organs meets the requirements of the protocol.
Locations
Other Locations
China
Cancer Hospital Chinese Academy of Medical Science
RECRUITING
Beijing
Hunan Cancer Hospital
RECRUITING
Changsha
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Cancer Hospital of Shandong First Medical University
RECRUITING
Jinan
Yunnan Cancer Hospital
RECRUITING
Kunming
Jiangxi Cancer Hospital
RECRUITING
Nanchang
Cancer Hospital of Guangxi Medical University
RECRUITING
Nanning
Shanghai Pulmonary Hospital (Affiliated to Tongji University)
RECRUITING
Shanghai
Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center
RECRUITING
Shenzhen
Shanxi Cancer Hospital
RECRUITING
Taiyuan
Taizhou Hospital of Zhejiang Province
RECRUITING
Taizhou
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Affiliated Cancer Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
Hubei Cancer Hospital
RECRUITING
Wuhan
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
Xiangyang Central Hospital
RECRUITING
Xiangyang
The First Affiliated Hospital of Zhengzhou University