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Trial Title: A Study of YL202 in Selected Patients With Advanced Solid Tumors

NCT ID: NCT06107686

Condition: NSCLC
Breast Cancer
HNSCC
Locally Advanced or Metastatic Solid Tumors

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
Antibody-drug conjugate

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: YL202 should be intravenously infused
Description: For each patient, YL202 should be intravenously infused over 60±10 min.
Arm group label: Corhort A
Arm group label: Corhort B
Arm group label: Corhort C
Arm group label: Corhort D

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.

Detailed description: 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 advanced NSCLC/BC/HNSCC/colorectal cancer/HER2-positive gastric cancer/cervical cancer/ovarian cancer and etc.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Anhui Tumour Hospital

Address:
City: Hefei
Country: China

Facility:
Name: The first affiliated hospital of Anhui Medical University

Address:
City: Hefei
Country: China

Facility:
Name: The Second Hospital of Anhui Medical University

Address:
City: Hefei
Country: China

Facility:
Name: Beijing Cancer hospital

Address:
City: Beijing
Country: China

Facility:
Name: Beijing Tsinghua Chang Gung Hospital

Address:
City: Beijing
Country: China

Facility:
Name: Peking University Third Hospital

Address:
City: Beijing
Country: China

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

Address:
City: Chongqing
Country: China

Facility:
Name: Chongqing University Affiliated Tumor Hospital

Address:
City: Chongqing
Country: China

Facility:
Name: The first affiliated hospital of Chongqing Medical University

Address:
City: Chongqing
Country: China

Facility:
Name: The Second Affiliated Hospital of Chongqing Medical University

Address:
City: Chongqing
Country: China

Facility:
Name: Xinqiao Hospital of AMU

Address:
City: Chongqing
Country: China

Facility:
Name: Xinqiao Hospital

Address:
City: Chongqing
Country: China

Facility:
Name: Fujian Tumor Hospital

Address:
City: Fuzhou
Country: China

Facility:
Name: Sun Yat-sen University Cancer Center

Address:
City: Guangzhou
Country: China

Facility:
Name: The First Affiliated Hospital of Sun Yat-sen University

Address:
City: Guangzhou
Country: China

Facility:
Name: The Sixth Affiliated Hospital of Sun Yat-Sen University

Address:
City: Guangzhou
Country: China

Facility:
Name: Zhujiang Hospital of Southern Medical University

Address:
City: Guangzhou
Country: China

Facility:
Name: Meizhou People's Hospital

Address:
City: Meizhou
Country: China

Facility:
Name: Shantou University Medical College Tumour Hospital

Address:
City: Shantou
Country: China

Facility:
Name: Guilin Medical College Second Affiliated Hospital

Address:
City: Guilin
Country: China

Facility:
Name: Guangxi Medical University Cancer Hospital

Address:
City: Nanning
Zip: 530021
Country: China

Facility:
Name: Guangxi Medical University Affiliated Tumour Hospital

Address:
City: Nanning
Country: China

Facility:
Name: The People's Hospital of Guangxi

Address:
City: Nanning
Country: China

Facility:
Name: Harbin Medical university cancer hospital

Address:
City: Harbin
Country: China

Facility:
Name: The First Affiliated Hospital Of Henan University&Technology

Address:
City: Luoyang
Country: China

Facility:
Name: The First Affiliated Hospital of Nanyang Medical College

Address:
City: Nanyang
Country: China

Facility:
Name: Xinxiang Medical University No.1 Affiliated Hospital

Address:
City: Xinxiang
Country: China

Facility:
Name: He'nan Cancer Hospital South Gate

Address:
City: Zhengzhou
Country: China

Facility:
Name: Henan Provincial Chest Hospital

Address:
City: Zhengzhou
Country: China

Facility:
Name: The First Affiliated Hospital of Zhengzhou University

Address:
City: Zhengzhou
Country: China

Facility:
Name: The First Peoples Hospital of Jingzhou

Address:
City: Jingzhou
Country: China

Facility:
Name: Hubei Cancer Hospital

Address:
City: Wuhan
Country: China

Facility:
Name: Tongji Hospital

Address:
City: Wuhan
Country: China

Facility:
Name: Union Hospital Tongji Medical College HuaZhong University of Science Technology

Address:
City: Wuhan
Country: China

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

Address:
City: Wuhan
Country: China

Facility:
Name: Xiangyang Central Hospital

Address:
City: Xiangyang
Country: China

Facility:
Name: Hu'nan Province Cancer Hospital

Address:
City: Changsha
Country: China

Facility:
Name: Hunan Provincial People's Hospital

Address:
City: Changsha
Country: China

Facility:
Name: Xiangya hospital Central South University

Address:
City: Changsha
Country: China

Facility:
Name: The Third People's Hospital of Hunan Province

Address:
City: Yueyang
Country: China

Facility:
Name: The Second Affiliated Hospital of Soochow University

Address:
City: Suzhou
Country: China

Facility:
Name: The Affiliated Hospital of Xuzhou medical University

Address:
City: Xuzhou
Country: China

Facility:
Name: Xuzhou Central Hospital

Address:
City: Xuzhou
Country: China

Facility:
Name: First Affiliated Hospital of Gannan Medical University

Address:
City: Ganzhou
Country: China

Facility:
Name: Jiangxi Cancer Hospital

Address:
City: Nanchang
Country: China

Facility:
Name: The Affiliated Hospital of NanChang University

Address:
City: Nanchang
Country: China

Facility:
Name: The Third Hospital of Nanchang

Address:
City: Nanchang
Country: China

Facility:
Name: Jilin Provincial Cancer Hospital

Address:
City: Changchun
Zip: 215000
Country: China

Facility:
Name: China-Japan Union Hospital of Jilin University

Address:
City: Changchun
Country: China

Facility:
Name: The second Hospital of Dalian Medical University

Address:
City: Dalian
Country: China

Facility:
Name: Fukuang General Hospital of Liaoning Health Industry Group

Address:
City: Fushun
Country: China

Facility:
Name: Liaoning Cancer Hospital & Institute

Address:
City: Shenyang
Country: China

Facility:
Name: The First Hospital of China Medical University Physical Examination Center

Address:
City: Shenyang
Country: China

Facility:
Name: Shandong Cancer Hospital

Address:
City: Jinan
Zip: 250117
Country: China

Facility:
Name: Jinan Central Hospital Affiliated to Shandong University

Address:
City: Jinan
Country: China

Facility:
Name: Shandong Cancer Hospital

Address:
City: Jinan
Country: China

Facility:
Name: Shandong Provincial Public Health Clinical Center

Address:
City: Jinan
Country: China

Facility:
Name: Affiliated Hospital of Jining Medical University

Address:
City: Jining
Country: China

Facility:
Name: Linyi Cancer hospital

Address:
City: Linyi
Country: China

Facility:
Name: The Affiliated Hospital of Qingdao University

Address:
City: Qingdao
Country: China

Facility:
Name: Weifang People's Hospital

Address:
City: Weifang
Country: China

Facility:
Name: Huashan Hospital affiliated to Fudan University