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

NCT07160335 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HLX17-MRST001
• Study Type: interventional
• Target: 174
• Locations: 4 countries
• Sites: 69

Brief 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).

Conditions

Renal Cell Carcinoma; Non-small Cell Lung Cancer; Melanoma

Outcome Measures

Primary Outcomes (2)

• AUC0-21d

  Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) after the 1st dose

  rom time 0 to 21 days after the 1st dose (3 weeks)

• AUCss

  Area under the serum concentration-time curve within a dosing interval at steady state (AUCss) after the 6th dose

  from time 0 to 21 days after the 6th dose (18 weeks)

Secondary Outcomes (11)

• maximum serum drug concentration (Cmax),

  up to 24 weeks

• trough serum drug concentration at steady state (Ctrough,ss)

  up to 24 weeks

• maximum serum drug concentration at steady state (Cmax,ss)

  up to 24 weeks

• trough serum drug concentration (Ctrough)

  up to 24 weeks

• DFS

  up to 12 months

Study Arms (2)

HLX17

EXPERIMENTAL

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).

Drug: HLX17

US-sourced Keytruda®

ACTIVE COMPARATOR

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).

Drug: HLX17; Drug: US-sourced Keytruda®

Interventions

US-sourced Keytruda® DRUG

Subjects will receive US-sourced Keytruda® (200 mg) on Day 1 of each 3-week cycle

Also known as: pembrolizumab

US-sourced Keytruda®

HLX17 DRUG

Subjects will receive HLX17 (200 mg) on Day 1 of each 3-week cycle

Also known as: pembrolizumab

HLX17; US-sourced Keytruda®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• Pregnant or lactating women.
• History of illicit drug use or alcohol abuse within 12 months prior to randomization in the investigator's judgment.
• 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).
• Participants with MEL have mucosal or ocular melanoma.
• Participants with RCC have pre-existing brain or bone metastatic lesions, or residual thrombus in the renal vein or vena cava after nephrectomy.
• Participants with other primary active malignancies within 5 years or at the same time prior to randomization.
• Have received an organ or bone marrow transplantation prior to randomization or scheduled for transplantation during the study.
• Presence of central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Symptomatic cerebrovascular disease or known myocardial infarction or poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females calculated by Fridericia's formula) within 6 months prior to randomization.
• 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%.
• Peripheral neuropathy greater than or equal to Grade 2 (CTCAE).
• 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.
• 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.
• Known severe allergic or anaphylactic reactions to pembrolizumab or any other monoclonal antibody or any components of the investigational medicinal products.
• Known active or suspected autoimmune diseases. Patients with stable disease who do not require systemic immunosuppressive therapy may also participate.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (69)

Oncology Physicians Network (OPN) - Glendale

Glendale, California, 91203, United States

RECRUITING

Oncology Physicians Network (OPN)- Los Alamitos

Los Alamitos, California, 90720, United States

RECRUITING

HCA

Los Angeles, California, 64132, United States

NOT YET RECRUITING

Los Angeles Cancer Network

Los Angeles, California, 92801, United States

NOT YET RECRUITING

Oncology Physicians Network (OPN) - San Bernardino

San Bernardino, California, 91203, United States

RECRUITING

BRCR Global

Deerfield Beach, Florida, 33326, United States

NOT YET RECRUITING

D&H National Research Center

Margate, Florida, 33063, United States

RECRUITING

Ocala Oncology

Ocala, Florida, 34474, United States

NOT YET RECRUITING

Mid Florida Hematology and oncology Center

Orange City, Florida, 32763, United States

RECRUITING

Oncology Consulatants (P1 Trials -Exigent Network)

Houston, Texas, 77030, United States

NOT YET RECRUITING

American Oncology Network Vista Oncology Division

Olympia, Washington, 98506, United States

NOT YET RECRUITING

Northwest Medical Specialties PPLC (P1 Trials - Exigent Network )

Tacoma, Washington, 98405, United States

NOT YET RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241004, China

RECRUITING

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China

RECRUITING

Hunan Provincial Cancer Hospital

Hunan, Changsha, 410031, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

The Second Hospital of Lanzhou University

Lanzhou, Gansu, 730030, China

RECRUITING

Cangzhou Central Hospital

Cangzhou, Hebei, 061012, China

NOT YET RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050035, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

NOT YET RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410006, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410028, China

NOT YET RECRUITING

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

NOT YET RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330001, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330200, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110042, China

RECRUITING

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

RECRUITING

Guangxi Medical University Cancer Center

Guangxi, Nanning, 530221, China

RECRUITING

Binzhou Medical University Hospital

Binzhou, Shandong, 256603, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

RECRUITING

Linyi Cancer Hospital

Linyi, Shandong, 276000, China

RECRUITING

ShangHai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, 710061, China

RECRUITING

Yuebei People's Hospital

Guangdong, Shaoguan, 512000, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

RECRUITING

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317000, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

The First Affiliated Hospital of Bengbu Medical College

Bengbu, 233000, China

RECRUITING

LTD High Technology Hospital Medcenter

Batumi, 6000, Georgia

NOT YET RECRUITING

JSC Vian

Kutaisi, 4600, Georgia

NOT YET RECRUITING

Israel- Georgian Medical Research Clinic Healthycore

Tbilisi, 0112, Georgia

NOT YET RECRUITING

High Technology Medical Center, University Clinic

Tbilisi, 0144, Georgia

NOT YET RECRUITING

St. Michael's Hospital LLC

Tbilisi, 0159, Georgia

NOT YET RECRUITING

TIM - Tbilisi Institute of Medicine LLC

Tbilisi, 0160, Georgia

NOT YET RECRUITING

Caucasus Medical Centre LLC

Tbilisi, 0186, Georgia

NOT YET RECRUITING

Adana City Training and Research Hospital

Adana, 1370, Turkey (Türkiye)

NOT YET RECRUITING

Dr. Abdurrahman Yurtaslan Ankara Training and Research Hospital

Ankara, 6200, Turkey (Türkiye)

NOT YET RECRUITING

Hacettepe University Oncology Hospital

Ankara, 6230, Turkey (Türkiye)

NOT YET RECRUITING

Ankara University Hospital

Ankara, 6590, Turkey (Türkiye)

NOT YET RECRUITING

Ankara Bilkent City Hospital Department of Medical Oncology

Ankara, 6800, Turkey (Türkiye)

NOT YET RECRUITING

Gaziantep City Hospital

Gaziantep, 27470, Turkey (Türkiye)

NOT YET RECRUITING

Yeditepe University Kosuyolu Hospital

Istanbul, 34718, Turkey (Türkiye)

NOT YET RECRUITING

Izmir Economy University Medical Point Hospital

Izmir, 35575, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Melanoma; Carcinoma, Renal Cell

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Lin Wu, MD

CONTACT

13170419973; wulin-calf@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 8, 2025
• Study Start: September 26, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): March 27, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (42); US (12); GE (7); TU (8)