New Keytruda-Like drug tested in cancer patients after surgery

NCT ID NCT07160335

Disease control Sponsor: Shanghai Henlius Biotech Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study tests a new drug called HLX17, which is similar to the cancer drug Keytruda. It is for people who have had surgery for non-small cell lung cancer, melanoma, or kidney cancer. The goal is to see how the drug moves through the body, how safe it is, and how well it works compared to Keytruda. About 174 adults aged 18 to 85 will take part.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 174 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

melanoma non-small cell lung carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma Non-small cell lung cancer Renal cell carcinoma

Contacts and locations

Locations

Adana City Training and Research Hospital

Adana, 1370, Turkey (Türkiye)
American Oncology Network Vista Oncology Division

Olympia, Washington, 98506, United States
Ankara Bilkent City Hospital Department of Medical Oncology

Ankara, 6800, Turkey (Türkiye)
Ankara University Hospital

Ankara, 6590, Turkey (Türkiye)
BRCR Global

Deerfield Beach, Florida, 33326, United States
Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China
Binzhou Medical University Hospital

Binzhou, Shandong, 256603, China
Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China
Cangzhou Central Hospital

Cangzhou, Hebei, 061012, China
Caucasus Medical Centre LLC

Tbilisi, 0186, Georgia
D&H National Research Center

Margate, Florida, 33063, United States
Dr. Abdurrahman Yurtaslan Ankara Training and Research Hospital

Ankara, 6200, Turkey (Türkiye)
Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China
Fujian Cancer Hospital

Fuzhou, Fujian, 350000, China
Gaziantep City Hospital

Gaziantep, 27470, Turkey (Türkiye)
Guangxi Medical University Cancer Center

Guangxi, Nanning, 530221, China
HCA

Los Angeles, California, 64132, United States
Hacettepe University Oncology Hospital

Ankara, 6230, Turkey (Türkiye)
High Technology Medical Center, University Clinic

Tbilisi, 0144, Georgia
Hubei Cancer Hospital

Wuhan, Hubei, 430079, China
Hunan Provincial Cancer Hospital

Hunan, Changsha, 410031, China
Israel- Georgian Medical Research Clinic Healthycore

Tbilisi, 0112, Georgia
Izmir Economy University Medical Point Hospital

Izmir, 35575, Turkey (Türkiye)
JSC Vian

Kutaisi, 4600, Georgia
Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330001, China
LTD High Technology Hospital Medcenter

Batumi, 6000, Georgia
Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110042, China
Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China
Linyi Cancer Hospital

Linyi, Shandong, 276000, China
Los Angeles Cancer Network

Los Angeles, California, 92801, United States
Mid Florida Hematology and oncology Center

Orange City, Florida, 32763, United States
Northwest Medical Specialties PPLC (P1 Trials - Exigent Network )

Tacoma, Washington, 98405, United States
Ocala Oncology

Ocala, Florida, 34474, United States
Oncology Consulatants (P1 Trials -Exigent Network)

Houston, Texas, 77030, United States
Oncology Physicians Network (OPN) - Glendale

Glendale, California, 91203, United States
Oncology Physicians Network (OPN) - San Bernardino

San Bernardino, California, 91203, United States
Oncology Physicians Network (OPN)- Los Alamitos

Los Alamitos, California, 90720, United States
Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China
ShangHai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China
Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China
Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China
Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China
St. Michael's Hospital LLC

Tbilisi, 0159, Georgia
TIM - Tbilisi Institute of Medicine LLC

Tbilisi, 0160, Georgia
Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317000, China
The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China
The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China
The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China
The First Affiliated Hospital of Bengbu Medical College

Bengbu, 233000, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330200, China
The First Affiliated Hospital of University of South China

Hengyang, Hunan, China
The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241004, China
The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China
The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, 710061, China
The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China
The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China
The First Hospital of Jilin University

Changchun, Jilin, 130000, China
The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050035, China
The Second Hospital of Lanzhou University

Lanzhou, Gansu, 730030, China
The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410006, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China
West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China
Xiangya Hospital of Central South University

Changsha, Hunan, 410028, China
Yeditepe University Kosuyolu Hospital

Istanbul, 34718, Turkey (Türkiye)
Yuebei People's Hospital

Guangdong, Shaoguan, 512000, China
Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China
Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China
Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China
Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

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