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NCT07160335PHASE1Recruiting

A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors

Shanghai Henlius Biotech

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

Inclusion Criteria: 1. 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. 2. At least 18 years and no older than 85 years (including 85 years old) at the time of signing the ICF. 3. 18 kg/m2 ≤ body mass index (BMI) ≤ 30 kg/m2 and 50 kg ≤ body weight ≤ 85 kg. 4. 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. 5. 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. 6. Have a life expectancy of at least 12 weeks. 7. 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) 8. Female patients must meet one of the following conditions: 1. Menopause (defined as no menstruation for at least 1 year with no confirmed cause other than menopause), or 2. Surgically sterilized (removal of the ovaries and/or uterus), or 3. 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 9. 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. Exclusion Criteria: 1. Pregnant or lactating women. 2. History of illicit drug use or alcohol abuse within 12 months prior to randomization in the investigator's judgment. 3. Participants with NSCLC have two synchronous primary non-small cell lung cancers or other histopathological types (such as mixed adenosquamous carcinoma, small cell lung cancer, or neuroendocrine carcinoma); known positive for EGFR sensitive mutations or ALK fusion. EGFR sensitive mutations include: exon 19 deletion mutation (19DEL) and exon 21 point mutation (21L858R). 4. Participants with MEL have mucosal or ocular melanoma. 5. Participants with RCC have pre-existing brain or bone metastatic lesions, or residual thrombus in the renal vein or vena cava after nephrectomy. 6. Participants with other primary active malignancies within 5 years or at the same time prior to randomization. 7. Have received an organ or bone marrow transplantation prior to randomization or scheduled for transplantation during the study. 8. Presence of central nervous system (CNS) metastases and/or carcinomatous meningitis. 9. Symptomatic cerebrovascular disease or known myocardial infarction or poorly controlled arrhythmia (including QTcF intervals ≥ 450 ms for males and ≥ 470 ms for females calculated by Fridericia's formula) within 6 months prior to randomization. 10. Chronic heart failure (Class III to IV based on NYHA classification) or an LVEF (left ventricular ejection fraction) assessed with the doppler echocardiography less than 50%. 11. Peripheral neuropathy greater than or equal to Grade 2 (CTCAE). 12. Known human immunodeficiency virus (HIV) infection (or positive anti-HIV during screening), or known Hepatitis B (or positive test for HBsAg or HBcAb and positive test for HBV-DNA during screening), or known Hepatitis C (or positive tests for HCV antibody and HCV-RNA during screening), or known Hepatitis B and C co-infection (or positive test for HBsAg or HBcAb and positive test for HCV antibody during screening), or active pulmonary tuberculosis within 6 months prior to randomization. 13. Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity prior to screening. 14. Known severe allergic or anaphylactic reactions to pembrolizumab or any other monoclonal antibody or any components of the investigational medicinal products. 15. Known active or suspected autoimmune diseases. Patients with stable disease who do not require systemic immunosuppressive therapy may also participate. 16. Unstable hyperthyroidism or hypothyroidism at screening. 17. Have received live vaccines within 28 days prior to the first dose in this study (Inactivated viral vaccines for seasonal influenza are allowed). 18. Treatment with systemic corticosteroids (\> 10 mg/day prednisone efficacy dosage) or other immunosuppressive drugs within 14 days prior to the first dose or during the study. However, participants are allowed to be enrolled under the following conditions: in the absence of active autoimmune disease, participants are allowed to use topical or inhaled steroids and adrenal hormone replacement therapy at dosages equivalent to ≤ 10 mg/day of prednisone efficacy. 19. Any active infection requiring systemic therapy within 1 month prior to the first dose in this study. 20. Participants have planning to undergo surgical treatment during this clinical trial. Tumor puncture or incisional lymph node biopsy is allowed. 21. Have received pembrolizumab or any other immune checkpoints inhibitors (PD-1, PD-L1, CTLA4, etc.) before randomization. 22. Participants have participated in a clinical study with another investigational medicinal product prior to randomization, and the interval between the current study and the previous study is too short: within 1 month prior to the first dose of the current study or within 5 half-lives of the previous investigational medicinal product (whichever is longer). Or planning to participate in a clinical study with another investigational medicinal product before completing all scheduled assessments in this clinical study. 23. Participants have participated in a device clinical study within 1 month prior to screening, or are participating in another surgical or device clinical study at the time of screening, or plan to participate in another surgical or device clinical study during this clinical study. 24. The investigator has a clear reason to believe that participation in this study would be detrimental to the participant.

Interventions

DRUG

HLX17

DRUG

US-sourced Keytruda®

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Conditions

Non-small Cell Lung CancerMelanomaRenal Cell Carcinoma

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)