Actively Recruiting
A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Study to Evaluate the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of HLX17 Versus US-sourced Keytruda® in Multiple Resected Solid Tumors
Led by Shanghai Henlius Biotech · Updated on 2026-05-15
174
Participants Needed
69
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to compare HLX17 and US-sourced Keytruda® in patients with resected non-small cell lung cancer, melanoma, or renal cell carcinoma. The study aims to evaluate how similar the pharmacokinetic profiles, efficacy, safety, and immune responses are between these two treatments in this patient population. Participants will receive either HLX17 or US-sourced Keytruda®. Those in the HLX17 group will get 200 mg on Day 1 of every 3-week cycle for up to 12 months or until disease recurrence, death, new anti-tumor therapy, unacceptable toxicity, consent withdrawal, or study end. The Keytruda® group will receive 200 mg every 3 weeks for 8 cycles (24 weeks), then switch to HLX17 on the same schedule until 12 months or similar conditions occur. During the study, participants will undergo various assessments including pharmacokinetic measurements such as drug concentration over time and at steady state, disease-free survival evaluation for up to 12 months, and monitoring for adverse events and laboratory abnormalities for up to 15 months. Safety follow-up includes vital signs, physical exams, ECGs, and immunogenicity evaluation. The total study duration includes treatment and safety monitoring phases.
CONDITIONS
Brief Title
A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form following regulatory guidelines
- Age between 18 and 85 years at consent
- Body mass index (BMI) between 18 and 30 kg/m2 and weight between 50 and 85 kg
- Diagnosed with one of the following resected solid tumors: non-small cell lung cancer after complete resection, melanoma after complete resection, or renal cell carcinoma at intermediate-high or high risk after nephrectomy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 within 7 days before first dose
- Life expectancy of at least 12 weeks
- Adequate organ function without recent blood transfusions or certain treatments within 14 days before first dose
- For females: menopause, surgical sterilization, or negative pregnancy test and agreement to use effective contraception or abstinence
- For males: agreement to use contraception or abstinence if partner is of childbearing potential
You will not qualify if you...
- Pregnant or breastfeeding women
- History of illicit drug use or alcohol abuse within 12 months prior to randomization
- Non-small cell lung cancer patients with multiple primary tumors or specific genetic mutations (EGFR or ALK)
- Melanoma patients with mucosal or ocular melanoma
- Renal cell carcinoma patients with brain or bone metastases or residual thrombus after nephrectomy
- Other active primary malignancies within 5 years prior to randomization
- Prior organ or bone marrow transplantation
- Presence of central nervous system metastases or carcinomatous meningitis
- Recent serious heart conditions including myocardial infarction or poor heart function
- Peripheral neuropathy Grade 2 or higher
- Known infections with HIV, Hepatitis B or C, or active tuberculosis
- Severe lung diseases affecting diagnosis or treatment
- Severe allergic reactions to pembrolizumab or similar antibodies
- Active or suspected autoimmune diseases unless stable without systemic immunosuppressive therapy
- Unstable thyroid conditions
- Recent live vaccines except seasonal influenza
- Recent systemic corticosteroid or immunosuppressive drug use above specified doses
- Active infection requiring treatment within 1 month before first dose
- Planned surgery during the study except biopsy
- Previous treatment with pembrolizumab or other immune checkpoint inhibitors
- Recent participation in other investigational drug or device studies within specified time frames
- Investigator judgment that participation is not in participant's best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months or until disease recurrence or other stopping criteria
Participants receive HLX17 or US-sourced Keytruda® as intravenous infusions on Day 1 of each 3-week cycle. Those starting on Keytruda® receive 8 cycles (24 weeks) before switching to HLX17 for up to 12 months after randomization, or until disease recurrence, death, new anti-tumor therapy, unacceptable toxicity, withdrawal, or study termination.
Participants have dosing visits every 3 weeks, up to nearly 17 cycles
Duration - Up to 90 days
Participants are monitored for safety and adverse events following treatment completion for up to 90 days.
Visits during a 90-day safety follow-up period
Trial Site Locations
Total: 69 locations
1
Oncology Physicians Network (OPN) - Glendale
Glendale, California, United States, 91203
Actively Recruiting
2
Oncology Physicians Network (OPN)- Los Alamitos
Los Alamitos, California, United States, 90720
Actively Recruiting
3
HCA
Los Angeles, California, United States, 64132
Not Yet Recruiting
4
Los Angeles Cancer Network
Los Angeles, California, United States, 92801
Not Yet Recruiting
5
Oncology Physicians Network (OPN) - San Bernardino
San Bernardino, California, United States, 91203
Actively Recruiting
6
BRCR Global
Deerfield Beach, Florida, United States, 33326
Not Yet Recruiting
7
D&H National Research Center
Margate, Florida, United States, 33063
Actively Recruiting
8
Ocala Oncology
Ocala, Florida, United States, 34474
Not Yet Recruiting
9
Mid Florida Hematology and oncology Center
Orange City, Florida, United States, 32763
Actively Recruiting
10
Oncology Consulatants (P1 Trials -Exigent Network)
Houston, Texas, United States, 77030
Not Yet Recruiting
11
American Oncology Network Vista Oncology Division
Olympia, Washington, United States, 98506
Not Yet Recruiting
12
Northwest Medical Specialties PPLC (P1 Trials - Exigent Network )
Tacoma, Washington, United States, 98405
Not Yet Recruiting
13
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
14
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China, 241004
Actively Recruiting
15
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 101149
Actively Recruiting
16
Hunan Provincial Cancer Hospital
Hunan, Changsha, China, 410031
Actively Recruiting
17
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
18
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
19
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China, 730030
Actively Recruiting
20
Cangzhou Central Hospital
Cangzhou, Hebei, China, 061012
Not Yet Recruiting
21
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050035
Actively Recruiting
22
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China, 453100
Not Yet Recruiting
23
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
24
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
25
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
26
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410006
Actively Recruiting
27
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410028
Not Yet Recruiting
28
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Not Yet Recruiting
29
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221006
Actively Recruiting
30
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330001
Actively Recruiting
31
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330200
Actively Recruiting
32
The First Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
33
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China, 110042
Actively Recruiting
34
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Actively Recruiting
35
Guangxi Medical University Cancer Center
Guangxi, Nanning, China, 530221
Actively Recruiting
36
Binzhou Medical University Hospital
Binzhou, Shandong, China, 256603
Actively Recruiting
37
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
38
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
39
Linyi Cancer Hospital
Linyi, Shandong, China, 276000
Actively Recruiting
40
ShangHai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
41
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
42
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
43
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
44
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Actively Recruiting
45
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China, 710061
Actively Recruiting
46
Yuebei People's Hospital
Guangdong, Shaoguan, China, 512000
Actively Recruiting
47
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
48
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
49
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Actively Recruiting
50
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
51
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
52
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China, 317000
Actively Recruiting
53
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
54
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China, 233000
Actively Recruiting
55
LTD High Technology Hospital Medcenter
Batumi, Georgia, 6000
Not Yet Recruiting
56
JSC Vian
Kutaisi, Georgia, 4600
Not Yet Recruiting
57
Israel- Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia, 0112
Not Yet Recruiting
58
High Technology Medical Center, University Clinic
Tbilisi, Georgia, 0144
Not Yet Recruiting
59
St. Michael's Hospital LLC
Tbilisi, Georgia, 0159
Not Yet Recruiting
60
TIM - Tbilisi Institute of Medicine LLC
Tbilisi, Georgia, 0160
Not Yet Recruiting
61
Caucasus Medical Centre LLC
Tbilisi, Georgia, 0186
Not Yet Recruiting
62
Adana City Training and Research Hospital
Adana, Turkey (Türkiye), 1370
Not Yet Recruiting
63
Dr. Abdurrahman Yurtaslan Ankara Training and Research Hospital
Ankara, Turkey (Türkiye), 6200
Not Yet Recruiting
64
Hacettepe University Oncology Hospital
Ankara, Turkey (Türkiye), 6230
Not Yet Recruiting
65
Ankara University Hospital
Ankara, Turkey (Türkiye), 6590
Not Yet Recruiting
66
Ankara Bilkent City Hospital Department of Medical Oncology
Ankara, Turkey (Türkiye), 6800
Not Yet Recruiting
67
Gaziantep City Hospital
Gaziantep, Turkey (Türkiye), 27470
Not Yet Recruiting
68
Yeditepe University Kosuyolu Hospital
Istanbul, Turkey (Türkiye), 34718
Not Yet Recruiting
69
Izmir Economy University Medical Point Hospital
Izmir, Turkey (Türkiye), 35575
Not Yet Recruiting
Research Team
L
Lin Wu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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