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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

Status: Recruiting
Location: See all (69) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Participants must have signed and dated an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines.

• At least 18 years and no older than 75 years (including 75 years old) at the time of signing the ICF.

• 18 kg/m2 ≤ body mass index (BMI) ≤ 30 kg/m2 and 50 kg ≤ body weight ≤ 85 kg.

• The patient with one of the following resected solid tumors:

‣ NSCLC patients after complete resection OR

⁃ Melanoma following complete resection OR

⁃ Renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

• Have a performance status of 0 on the Eastern Cooperative Oncology Group (ECOG) Performance Status within 7 days prior to the first dose in this study.

• Have a life expectancy of at least 12 weeks.

• Have adequate organ function as indicated by the following laboratory values (no blood transfusions, or treatment with albumin, recombinant human thrombopoietin or colony-stimulating factor within 14 days prior to the first dose in this study)

• Female patients must meet one of the following conditions:

∙ Menopause (defined as no menstruation for at least 1 year with no confirmed cause other than menopause), or

‣ Surgically sterilized (removal of the ovaries and/or uterus), or

‣ Fertile, but must:

⁃ be tested negative for serum/urine pregnancy test within 7 days prior to the randomization, and

• agree to use contraception methods with an annual failure rate of \< 1% or to remain abstinent (avoid heterosexual intercourse from signing the ICF to at least 6 months after the last dose of the study drug) (a contraceptive method with an annual failure rate of \< 1% includes bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that can inhibit ovulation, hormone-releasing intrauterine devices and copper-containing intrauterine devices or condoms), and

• not breastfeed

• Male patients must: agree to remain abstinent (avoid heterosexual intercourse) or take contraception measures as follows: male patients with a pregnant partner or a partner of childbearing potential must remain abstinent or use condoms to prevent drug exposure to the embryo during study treatment and for at least 6 months after the last dose of study drug. Periodic abstinence (e.g., contraception based on calendar day, ovulatory phase, basal body temperature, or postovulatory phase) and external ejaculation are ineligible methods of contraception.

Locations
United States
California
Oncology Physicians Network (OPN) - Glendale
RECRUITING
Glendale
Oncology Physicians Network (OPN)- Los Alamitos
RECRUITING
Los Alamitos
HCA
NOT_YET_RECRUITING
Los Angeles
Los Angeles Cancer Network
NOT_YET_RECRUITING
Los Angeles
Oncology Physicians Network (OPN) - San Bernardino
RECRUITING
San Bernardino
Florida
BRCR Global
NOT_YET_RECRUITING
Deerfield Beach
D&H National Research Center
RECRUITING
Margate
Ocala Oncology
NOT_YET_RECRUITING
Ocala
Mid Florida Hematology and oncology Center
RECRUITING
Orange City
Texas
Oncology Consulatants (P1 Trials -Exigent Network)
NOT_YET_RECRUITING
Houston
Washington
American Oncology Network Vista Oncology Division
NOT_YET_RECRUITING
Olympia
Northwest Medical Specialties PPLC (P1 Trials - Exigent Network )
NOT_YET_RECRUITING
Tacoma
Other Locations
China
Beijing Chest Hospital, Capital Medical University
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
RECRUITING
Bengbu
Binzhou Medical University Hospital
RECRUITING
Binzhou
Cangzhou Central Hospital
NOT_YET_RECRUITING
Cangzhou
The First Hospital of Jilin University
RECRUITING
Changchun
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Sichuan Cancer Hospital
RECRUITING
Chengdu
West China Hospital of Sichuan University
RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Yuebei People's Hospital
RECRUITING
Guangdong
Guangxi Medical University Cancer Center
RECRUITING
Guangxi
The First Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
The First Affiliated Hospital of University of South China
NOT_YET_RECRUITING
Hengyang
Hunan Provincial Cancer Hospital
RECRUITING
Hunan
Cancer Hospital of Shandong First Medical University
RECRUITING
Jinan
Qilu Hospital of Shandong University
RECRUITING
Jinan
Yunnan Cancer Hospital
RECRUITING
Kunming
The Second Hospital of Lanzhou University
RECRUITING
Lanzhou
Linyi Cancer Hospital
RECRUITING
Linyi
Jiangxi Cancer Hospital
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Shanghai Chest Hospital
RECRUITING
Shanghai
ShangHai Pulmonary Hospital
RECRUITING
Shanghai
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Liaoning Cancer Hospital and Institute
RECRUITING
Shenyang
Liaoning Cancer Hospital and Institute
RECRUITING
Shenyang
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Taizhou Hospital of Zhejiang Province
RECRUITING
Taizhou
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Hubei Cancer Hospital
RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
The First Affiliated Hospital of Wannan Medical College
RECRUITING
Wuhu
The First Affiliated Hospital of Xi'an Jiao Tong University
RECRUITING
Xi’an
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
The First Affiliated Hospital of Xinxiang Medical University
NOT_YET_RECRUITING
Xinxiang
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Georgia
LTD High Technology Hospital Medcenter
NOT_YET_RECRUITING
Batumi
JSC Vian
NOT_YET_RECRUITING
Kutaisi
Caucasus Medical Centre LLC
NOT_YET_RECRUITING
Tbilisi
High Technology Medical Center, University Clinic
NOT_YET_RECRUITING
Tbilisi
Israel- Georgian Medical Research Clinic Healthycore
NOT_YET_RECRUITING
Tbilisi
St. Michael's Hospital LLC
NOT_YET_RECRUITING
Tbilisi
TIM - Tbilisi Institute of Medicine LLC
NOT_YET_RECRUITING
Tbilisi
Turkey
Adana City Training and Research Hospital
NOT_YET_RECRUITING
Adana
Ankara Bilkent City Hospital Department of Medical Oncology
NOT_YET_RECRUITING
Ankara
Ankara University Hospital
NOT_YET_RECRUITING
Ankara
Dr. Abdurrahman Yurtaslan Ankara Training and Research Hospital
NOT_YET_RECRUITING
Ankara
Hacettepe University Oncology Hospital
NOT_YET_RECRUITING
Ankara
Gaziantep City Hospital
NOT_YET_RECRUITING
Gaziantep
Yeditepe University Kosuyolu Hospital
NOT_YET_RECRUITING
Istanbul
Izmir Economy University Medical Point Hospital
NOT_YET_RECRUITING
Izmir
Contact Information
Primary
Lin Wu, MD
wulin-calf@vip.163.com
13170419973
Time Frame
Start Date: 2025-09-26
Estimated Completion Date: 2028-03-27
Participants
Target number of participants: 174
Treatments
Experimental: HLX17
Subjects will receive HLX17 (200 mg) on Day 1 of each 3-week cycle, until 12 months after the randomization (nearly 17 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first).
Active_comparator: US-sourced Keytruda®
Subjects will receive US-sourced Keytruda® (200 mg) on Day 1 of each 3-week cycle, for a total of 8 cycles (24 weeks). After 8 cycles, all subjects in the US-sourced Keytruda® group will receive HLX17 200 mg on Day 1 of each 3-week cycle until 12 months after the randomization (nearly 17 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first).
Sponsors
Leads: Shanghai Henlius Biotech

This content was sourced from clinicaltrials.gov

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