RecruitingPhase 1NCT07160335

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

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

Sponsor

Shanghai Henlius Biotech

Enrollment

174 participants

Start Date

Sep 26, 2025

Study Type

INTERVENTIONAL

Conditions

Melanoma Non-small Cell Lung Cancer Renal Cell Carcinoma

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 trial compares HLX17 (a biosimilar version of pembrolizumab, a well-known immune checkpoint drug) to the original Keytruda® in patients who have had their solid tumors surgically removed. The goal is to check if the two drugs behave the same way in the body — confirming the biosimilar works as expected. **You may be eligible if...** - You are between 18 and 75 years old - You have had complete surgical removal of non-small cell lung cancer, melanoma, or kidney cancer (with intermediate-high or high risk of recurrence) - Your ECOG performance status is 0 (fully active) - Your BMI is between 18 and 30 kg/m² and you weigh between 50 and 85 kg **You may NOT be eligible if...** - Your cancer has not been completely removed surgically - You have active autoimmune disease or require immune-suppressing medications - You have significant organ dysfunction or serious comorbidities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHLX17

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

DRUGUS-sourced Keytruda®

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

Locations(69)

Oncology Physicians Network (OPN) - Glendale

Glendale, California, United States

Oncology Physicians Network (OPN)- Los Alamitos

Los Alamitos, California, United States

HCA

Los Angeles, California, United States

Los Angeles Cancer Network

Los Angeles, California, United States

Oncology Physicians Network (OPN) - San Bernardino

San Bernardino, California, United States

BRCR Global

Deerfield Beach, Florida, United States

D&H National Research Center

Margate, Florida, United States

Ocala Oncology

Ocala, Florida, United States

Mid Florida Hematology and oncology Center

Orange City, Florida, United States

Oncology Consulatants (P1 Trials -Exigent Network)

Houston, Texas, United States

American Oncology Network Vista Oncology Division

Olympia, Washington, United States

Northwest Medical Specialties PPLC (P1 Trials - Exigent Network )

Tacoma, Washington, United States

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Hunan Provincial Cancer Hospital

Hunan, Changsha, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

The Second Hospital of Lanzhou University

Lanzhou, Gansu, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Guangxi Medical University Cancer Center

Guangxi, Nanning, China

Binzhou Medical University Hospital

Binzhou, Shandong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

ShangHai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China

Yuebei People's Hospital

Guangdong, Shaoguan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

LTD High Technology Hospital Medcenter

Batumi, Georgia

JSC Vian

Kutaisi, Georgia

Israel- Georgian Medical Research Clinic Healthycore

Tbilisi, Georgia

High Technology Medical Center, University Clinic

Tbilisi, Georgia

St. Michael's Hospital LLC

Tbilisi, Georgia

TIM - Tbilisi Institute of Medicine LLC

Tbilisi, Georgia

Caucasus Medical Centre LLC

Tbilisi, Georgia

Adana City Training and Research Hospital

Adana, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Training and Research Hospital

Ankara, Turkey (Türkiye)

Hacettepe University Oncology Hospital

Ankara, Turkey (Türkiye)

Ankara University Hospital

Ankara, Turkey (Türkiye)

Ankara Bilkent City Hospital Department of Medical Oncology

Ankara, Turkey (Türkiye)

Gaziantep City Hospital

Gaziantep, Turkey (Türkiye)

Yeditepe University Kosuyolu Hospital

Istanbul, Turkey (Türkiye)

Izmir Economy University Medical Point Hospital

Izmir, Turkey (Türkiye)

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