A Study of YL202 in Selected Patients with Advanced Solid Tumors

Last updated: November 13, 2024
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Breast Cancer

Neoplasms

Treatment

YL202 should be intravenously infused

Clinical Study ID

NCT06107686
YL202-CN-201-01
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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/otherlocally advanced or metastatic solid tumors including but not limited to colorectalcancer, 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

  7. The function of organs and bone marrow meets the requirements within 7 days beforethe first dose.

  8. Female subjects of childbearing potential must agree to adopt highly effectivecontraceptive measures from screening throughout the study period and within atleast 6 months after the last dose of the investigational product. Male subjectsmust agree to adopt highly effective contraceptive measures from screeningthroughout the study period and within at least 6 months after the last dose of theinvestigational product.

  9. With expected survival ≥ 3 months.

  10. Be capable of and willing to comply with the visits and procedures stipulated in thestudy protocol.

Exclusion

Exclusion Criteria:

  1. With prior drug therapy targeting HER3 (including antibodies, antibody-drugconjugates [ADCs]), chimeric antigen receptor T-cell immunotherapy (CAR-T), andother drugs).

  2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed oftopoisomerase 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 interventionalstudy.

  4. The washout period from the previous anti-tumor therapy is insufficient before thefirst dose of the investigational product.

  5. Patients who have received major surgery (excluding diagnostic surgery) within 4weeks before the first dose of the investigational product or those who are expectedto receive major surgery during the study.

  6. Prior treatment with allogeneic bone marrow transplantation or solid organtransplantation.

  7. Prior treatment with systemic steroids (prednisone > 10 mg/day or equivalent) orother immunosuppressive treatment within 2 weeks before the first dose of theinvestigational product.

  8. Patients who have received any live vaccine within 4 weeks before the first dose ofthe investigational product or those who plan to receive live vaccine during thestudy 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 6months before the first dose, or with active gastric and duodenal ulcers, ulcerativecolitis, or other gastrointestinal diseases that may lead to hemorrhage orperforation 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 thefirst 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 rawmaterials and drug product or other monoclonal antibodies.

  22. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3days before the first dose.

  23. With any diseases, medical conditions, organ system dysfunction, or socialconditions 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 mentalillness or substance/alcohol abuse, in the opinion of the investigator.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: YL202 should be intravenously infused
Phase: 2
Study Start date:
December 15, 2023
Estimated Completion Date:
November 30, 2028

Study 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.

Connect with a study center

  • Anhui Tumour Hospital

    Hefei, Anhui
    China

    Active - Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Site Not Available

  • The first affiliated hospital of Anhui Medical University

    Hefei, Anhui
    China

    Active - Recruiting

  • Beijing Cancer hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Beijing Tsinghua Chang Gung Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing
    China

    Active - Recruiting

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

    Chongqing, Chongqing
    China

    Site Not Available

  • Chongqing University Affiliated Tumor Hospital

    Chongqing, Chongqing
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing
    China

    Site Not Available

  • The Third Affiliated Hospital of the Chinese Army Medical University of the People's Liberation Army

    Chongqing, Chongqing
    China

    Site Not Available

  • The first affiliated hospital of Chongqing Medical University

    Chongqing, Chongqing
    China

    Site Not Available

  • Xinqiao Hospital

    Chongqing, Chongqing
    China

    Active - Recruiting

  • Xinqiao Hospital of AMU

    Chongqing, Chongqing
    China

    Active - Recruiting

  • Fujian Tumor Hospital

    Fuzhou, Fujian
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong
    China

    Site Not Available

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Meizhou People's Hospital

    Meizhou, Guangdong
    China

    Active - Recruiting

  • Shantou University Medical College Tumour Hospital

    Shantou, Guangdong
    China

    Active - Recruiting

  • Guilin Medical College Second Affiliated Hospital

    Guilin, Guangxi
    China

    Active - Recruiting

  • The Second Affiliated Hospital Of Guilin medical University

    Guilin, Guangxi
    China

    Site Not Available

  • Guangxi Medical University Affiliated Tumour Hospital

    Nanning, Guangxi
    China

    Active - Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi 530021
    China

    Active - Recruiting

  • The People's Hospital of Guangxi

    Nanning, Guangxi
    China

    Active - Recruiting

  • Harbin Medical university cancer hospital

    Harbin, Heilongjiang
    China

    Active - Recruiting

  • The First Affiliated Hospital Of Henan University&Technology

    Luoyang, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan
    China

    Active - Recruiting

  • Xinxiang Medical University No.1 Affiliated Hospital

    Xinxiang, Henan
    China

    Active - Recruiting

  • He'nan Cancer Hospital South Gate

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Henan Provincial Chest Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

  • The First Peoples Hospital of Jingzhou

    Jingzhou, Hubei
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

  • Tongji Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College HuaZhong University of Science Technology

    Wuhan, Hubei
    China

    Site Not Available

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

    Wuhan, Hubei
    China

    Active - Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei
    China

    Site Not Available

  • Hu'nan Province Cancer Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • Hunan Provincial People's Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • Xiangya hospital Central South University

    Changsha, Hunan
    China

    Active - Recruiting

  • The Third People's Hospital of Hunan Province

    Yueyang, Hunan
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou medical University

    Xuzhou, Jiangsu
    China

    Active - Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu
    China

    Active - Recruiting

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi
    China

    Site Not Available

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi
    China

    Site Not Available

  • The Affiliated Hospital of NanChang University

    Nanchang, Jiangxi
    China

    Site Not Available

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • Jilin Provincial Cancer Hospital

    Chang chun, Jilin 130012
    China

    Site Not Available

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin
    China

    Active - Recruiting

  • Jilin Provincial Cancer Hospital

    Changchun, Jilin 215000
    China

    Active - Recruiting

  • The second Hospital of Dalian Medical University

    Dalian, Liaoning
    China

    Site Not Available

  • Fukuang General Hospital of Liaoning Health Industry Group

    Fushun, Liaoning
    China

    Site Not Available

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning
    China

    Active - Recruiting

  • The First Hospital of China Medical University Physical Examination Center

    Shenyang, Liaoning
    China

    Site Not Available

  • Jinan Central Hospital Affiliated to Shandong University

    Jinan, Shandong
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong
    China

    Site Not Available

  • Shandong Provincial Public Health Clinical Center

    Jinan, Shandong
    China

    Site Not Available

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong
    China

    Site Not Available

  • Linyi Cancer hospital

    Linyi, Shandong
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong
    China

    Active - Recruiting

  • Weifang People's Hospital

    Weifang, Shandong
    China

    Site Not Available

  • Huashan Hospital affiliated to Fudan University

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Shanghai Ninth People's Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • The Affiliated Huashan Hospital of Fudan University

    Shanghai, Shanghai
    China

    Site Not Available

  • The No.10 Peoples Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Shanxi Province Cancer Hospital

    Taiyuan, Shanxi
    China

    Site Not Available

  • The First Affiliated Hospital Of Xi'an JiaoTong University

    Xian, Shanxi
    China

    Site Not Available

  • SiChuan Cancer Hospital

    Chengdu, Sichuan
    China

    Site Not Available

  • Sichuan Cancer Hospital

    Chengdu, Sichuan
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

  • West China Hospital,Sichuan Universtiy

    Chengdu, Sichuan
    China

    Site Not Available

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Urumqi, Xinjiang
    China

    Site Not Available

  • Yunnan Tumor Hospital

    Kunming, Yunnan
    China

    Active - Recruiting

  • The Second Affiliated Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University school of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

  • ZheJiang Cancer Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Zhejiang Province People's Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Zhejiang University Medical College Affiliated No.1 Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Yiwu Central Hospital

    Jinhua, Zhejiang
    China

    Active - Recruiting

  • Taizhou Hospital of Zhejiang

    Taizhou, Zhejiang
    China

    Active - Recruiting

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