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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors
Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.
Summary
This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.
Official title: A First-in-Human, Open-Label, Multi-Center Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK201 for Injection in Adult Participants With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
202
Start Date
2024-10-24
Completion Date
2028-04-22
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
ALK201
Administered intravenously, once every 3 weeks
Locations (38)
Denver Drug Development Unit
Denver, Colorado, United States
UCF Lake Nona Cancer Center
Orlando, Florida, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States
Cancer Care Wollongong
Wollongong, New South Wales, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia
Mater Cancer Care Center
South Brisbane, Queensland, Australia
Macquarie University Hospital
Macquarie, Australia
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian, China
Guangdong Province People's Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Cancer Hospital Of Shantou University Medical College
Shantou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
Harbin Medical University Canser Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of Hust
Wuhan, Hubei, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Xuzhou Central Hospital ( Southeast University Affiliated Hopstal )
Xuzhou, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital Zhejiang University School of Medical
Hangzhou, Zhejiang, China
The First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
ChongQing University Cancer Hospital
Chongqing, China