A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors
Start Date
9/26/2025
Completion Date
3/27/2028
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).
Eligibility Criteria
Age Range: 18 years to 85 years
Interventions
HLX17
US-sourced Keytruda®
Conditions
Locations
Oncology Physicians Network (OPN) - Glendale
Glendale, California 91203
United States
Oncology Physicians Network (OPN)- Los Alamitos
Los Alamitos, California 90720
United States
HCA
Los Angeles, California 64132
United States
Los Angeles Cancer Network
Los Angeles, California 92801
United States
Oncology Physicians Network (OPN) - San Bernardino
San Bernardino, California 91203
United States
BRCR Global
Deerfield Beach, Florida 33326
United States
D&H National Research Center
Margate, Florida 33063
United States
Ocala Oncology
Ocala, Florida 34474
United States
Mid Florida Hematology and oncology Center
Orange City, Florida 32763
United States
Oncology Consulatants (P1 Trials -Exigent Network)
Houston, Texas 77030
United States
American Oncology Network Vista Oncology Division
Olympia, Washington 98506
United States
Northwest Medical Specialties PPLC (P1 Trials - Exigent Network )
Tacoma, Washington 98405
United States
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui 230022
China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui 241004
China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality 101149
China
Hunan Provincial Cancer Hospital
Hunan, Changsha 410031
China
Fujian Cancer Hospital
Fuzhou, Fujian 350000
China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian 361003
China
The Second Hospital of Lanzhou University
Lanzhou, Gansu 730030
China
Cangzhou Central Hospital
Cangzhou, Hebei 061012
China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei 050035
China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan 453100
China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei 430022
China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei 430071
China
Hubei Cancer Hospital
Wuhan, Hubei 430079
China
The Third Xiangya Hospital of Central South University
Changsha, Hunan 410006
China
Xiangya Hospital of Central South University
Changsha, Hunan 410028
China
The First Affiliated Hospital of University of South China
Hengyang, Hunan
China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu 221006
China
Jiangxi Cancer Hospital
Nanchang, Jiangxi 330001
China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330200
China
The First Hospital of Jilin University
Changchun, Jilin 130000
China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning 110042
China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning
China
Guangxi Medical University Cancer Center
Guangxi, Nanning 530221
China
Binzhou Medical University Hospital
Binzhou, Shandong 256603
China
Qilu Hospital of Shandong University
Jinan, Shandong 250012
China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong 250117
China
Linyi Cancer Hospital
Linyi, Shandong 276000
China
ShangHai Pulmonary Hospital
Shanghai, Shanghai Municipality 200000
China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality 200030
China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality 200032
China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality 200032
China
Shanxi Bethune Hospital
Taiyuan, Shanxi 030032
China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi 710061
China
Yuebei People's Hospital
Guangdong, Shaoguan 512000
China
West China Hospital of Sichuan University
Chengdu, Sichuan 610000
China
Sichuan Cancer Hospital
Chengdu, Sichuan 610041
China
Yunnan Cancer Hospital
Kunming, Yunnan 650118
China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310022
China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang 317000
China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325000
China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233000
China
LTD High Technology Hospital Medcenter
Batumi, 6000
Georgia
JSC Vian
Kutaisi, 4600
Georgia
Israel- Georgian Medical Research Clinic Healthycore
Tbilisi, 0112
Georgia
High Technology Medical Center, University Clinic
Tbilisi, 0144
Georgia
St. Michael's Hospital LLC
Tbilisi, 0159
Georgia
TIM - Tbilisi Institute of Medicine LLC
Tbilisi, 0160
Georgia
Caucasus Medical Centre LLC
Tbilisi, 0186
Georgia
Adana City Training and Research Hospital
Adana, 1370
Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Training and Research Hospital
Ankara, 6200
Turkey (Türkiye)
Hacettepe University Oncology Hospital
Ankara, 6230
Turkey (Türkiye)
Ankara University Hospital
Ankara, 6590
Turkey (Türkiye)
Ankara Bilkent City Hospital Department of Medical Oncology
Ankara, 6800
Turkey (Türkiye)
Gaziantep City Hospital
Gaziantep, 27470
Turkey (Türkiye)
Yeditepe University Kosuyolu Hospital
Istanbul, 34718
Turkey (Türkiye)
Izmir Economy University Medical Point Hospital
Izmir, 35575
Turkey (Türkiye)