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RECRUITING

NCT06107686

PHASE2

A Study of YL202 in Selected Patients With Advanced Solid Tumors

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the following selected patients with advanced solid tumors.

Official title: A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-12-15

Completion Date

2028-11

Last Updated

2025-11-26

Healthy Volunteers

Conditions

NSCLC Breast Cancer HNSCC Locally Advanced or Metastatic Solid Tumors

Interventions

DRUG

YL202 should be intravenously infused

For each patient, YL202 should be intravenously infused over 60±10 min.

Inclusion Criteria: 1. Subjects who are aware of relevant trial information before the start of the trial, and voluntarily sign and date on the informed consent form (ICF). 2. Subjects aged from 18-75 (inclusive) years. 3. Histologically or cytologically confirmed at diagnosis of NSCLC/BC/HNSCC/other locally advanced or metastatic solid tumors including but not limited to colorectal cancer, HER2-positive gastric cancer, cervical cancer, ovarian cancer, etc.. 4. At least one extracranial measurable lesion according to RECIST 1.1. 5. Archived or fresh tumor tissue samples can be provided. 6. With Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. 7. The function of organs and bone marrow meets the requirements within 7 days before the first dose. 8. Female subjects of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. Male subjects must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. 9. With expected survival ≥ 3 months. 10. Be capable of and willing to comply with the visits and procedures stipulated in the study protocol. Exclusion Criteria: 1. With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates \[ADCs\]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs). 2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors. 3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study. 4. The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product. 5. Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study. 6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation. 7. Prior treatment with systemic steroids (prednisone \> 10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product. 8. Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period. 9. With meningeal metastasis or cancerous meningitis. 10. With brain metastasis or spinal cord compression. 11. Patients with uncontrolled or clinically significant cardiovascular diseases. 12. Clinically significant complicated pulmonary disorders. 13. Patients diagnosed with Gilbert syndrome. 14. Those with uncontrolled effusion in the third space requiring repeated drainage. 15. With a medical history of gastrointestinal perforation and/or fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may lead to hemorrhage or perforation according to the investigator. 16. With serious infection before the first dose. 17. With known human immunodeficiency virus (HIV) infection. 18. With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 19. With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product. 20. Unrelieved toxicity of previous anti-tumor therapy. 21. With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies. 22. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose. 23. With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of subjects to sign the ICF, adversely affect the ability of subjects to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance/alcohol abuse, in the opinion of the investigator.

Locations (82)

Anhui Tumour Hospital

Hefei, Anhui, China

The first affiliated hospital of Anhui Medical University

Hefei, Anhui, China

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Cancer hospital

Beijing, Beijing Municipality, China

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Chinese First Affiliated Hospital of Army Medical University of the People's Liberation Army

Chongqing, Chongqing Municipality, China

Chongqing University Affiliated Tumor Hospital

Chongqing, Chongqing Municipality, China

The first affiliated hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Xinqiao Hospital of AMU

Chongqing, Chongqing Municipality, China

Xinqiao Hospital

Chongqing, Chongqing Municipality, China

Fujian Tumor Hospital

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

Shantou University Medical College Tumour Hospital

Shantou, Guangdong, China

Guilin Medical College Second Affiliated Hospital

Guilin, Guangxi, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Guangxi Medical University Affiliated Tumour Hospital

Nanning, Guangxi, China

The People's Hospital of Guangxi

Nanning, Guangxi, China

Harbin Medical university cancer hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital Of Henan University&Technology

Luoyang, Henan, China

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

Xinxiang Medical University No.1 Affiliated Hospital

Xinxiang, Henan, China

He'nan Cancer Hospital South Gate

Zhengzhou, Henan, China

Henan Provincial Chest Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The First Peoples Hospital of Jingzhou

Jingzhou, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Tongji Hospital

Wuhan, Hubei, China

Union Hospital Tongji Medical College HuaZhong University of Science Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Hu'nan Province Cancer Hospital

Changsha, Hunan, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

Xiangya hospital Central South University

Changsha, Hunan, China

The Third People's Hospital of Hunan Province

Yueyang, Hunan, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The Affiliated Hospital of Xuzhou medical University

Xuzhou, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The Affiliated Hospital of NanChang University

Nanchang, Jiangxi, China

The Third Hospital of Nanchang

Nanchang, Jiangxi, China

Jilin Provincial Cancer Hospital

Changchun, Jilin, China

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

The second Hospital of Dalian Medical University

Dalian, Liaoning, China

Fukuang General Hospital of Liaoning Health Industry Group

Fushun, Liaoning, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

The First Hospital of China Medical University Physical Examination Center

Shenyang, Liaoning, China

Shandong Cancer Hospital

Jinan, Shandong, China

Jinan Central Hospital Affiliated to Shandong University

Jinan, Shandong, China

Shandong Cancer Hospital

Jinan, Shandong, China

Shandong Provincial Public Health Clinical Center

Jinan, Shandong, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

Linyi Cancer hospital

Linyi, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Weifang People's Hospital

Weifang, Shandong, China

Huashan Hospital affiliated to Fudan University