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A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors
Sponsor: Shanghai Henlius Biotech
Summary
This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety, and immunogenicity of HLX17 vs. US-sourced Keytruda® in patients with resected non-small cell lung cancer (NSCLC) or melanoma (MEL), or renal cell carcinoma (RCC).
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® (US-sourced Keytruda®) in Multiple Resected Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
174
Start Date
2025-09-26
Completion Date
2028-03-27
Last Updated
2026-02-13
Healthy Volunteers
No
Interventions
HLX17
Subjects will receive HLX17 (200 mg) on Day 1 of each 3-week cycle
US-sourced Keytruda®
Subjects will receive US-sourced Keytruda® (200 mg) on Day 1 of each 3-week cycle
Locations (69)
Oncology Physicians Network (OPN) - Glendale
Glendale, California, United States
Oncology Physicians Network (OPN)- Los Alamitos
Los Alamitos, California, United States
HCA
Los Angeles, California, United States
Los Angeles Cancer Network
Los Angeles, California, United States
Oncology Physicians Network (OPN) - San Bernardino
San Bernardino, California, United States
BRCR Global
Deerfield Beach, Florida, United States
D&H National Research Center
Margate, Florida, United States
Ocala Oncology
Ocala, Florida, United States
Mid Florida Hematology and oncology Center
Orange City, Florida, United States
Oncology Consulatants (P1 Trials -Exigent Network)
Houston, Texas, United States
American Oncology Network Vista Oncology Division
Olympia, Washington, United States
Northwest Medical Specialties PPLC (P1 Trials - Exigent Network )
Tacoma, Washington, United States
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Hunan Provincial Cancer Hospital
Hunan, Changsha, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Guangxi Medical University Cancer Center
Guangxi, Nanning, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
ShangHai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China
Yuebei People's Hospital
Guangdong, Shaoguan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
LTD High Technology Hospital Medcenter
Batumi, Georgia
JSC Vian
Kutaisi, Georgia
Israel- Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
High Technology Medical Center, University Clinic
Tbilisi, Georgia
St. Michael's Hospital LLC
Tbilisi, Georgia
TIM - Tbilisi Institute of Medicine LLC
Tbilisi, Georgia
Caucasus Medical Centre LLC
Tbilisi, Georgia
Adana City Training and Research Hospital
Adana, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Training and Research Hospital
Ankara, Turkey (Türkiye)
Hacettepe University Oncology Hospital
Ankara, Turkey (Türkiye)
Ankara University Hospital
Ankara, Turkey (Türkiye)
Ankara Bilkent City Hospital Department of Medical Oncology
Ankara, Turkey (Türkiye)
Gaziantep City Hospital
Gaziantep, Turkey (Türkiye)
Yeditepe University Kosuyolu Hospital
Istanbul, Turkey (Türkiye)
Izmir Economy University Medical Point Hospital
Izmir, Turkey (Türkiye)