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Clinical Trials in China / NCT06107686
Recruiting Phase 2

A Study of YL202 in Selected Patients With Advanced Solid Tumors

NCT06107686 · tracked via the Priya Life Science China tracker
Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Phase
Phase 2
Started
2023-12-15
Last updated
2025-11-26

Condition(s) studied

NSCLCBreast CancerHNSCCLocally Advanced or Metastatic Solid Tumors

Investigational drug(s) / intervention(s)

YL202 should be intravenously infused

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

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (82)

FacilityCityRegionStatus
Anhui Tumour Hospital Hefei Anhui Recruiting
The first affiliated hospital of Anhui Medical University Hefei Anhui Recruiting
The Second Hospital of Anhui Medical University Hefei Anhui Not Yet Recruiting
Beijing Cancer hospital Beijing Beijing Municipality Recruiting
Beijing Tsinghua Chang Gung Hospital Beijing Beijing Municipality Not Yet Recruiting
Peking University Third Hospital Beijing Beijing Municipality Recruiting
Chinese First Affiliated Hospital of Army Medical University of the People's Liberation Army Chongqing Chongqing Municipality Not Yet Recruiting
Chongqing University Affiliated Tumor Hospital Chongqing Chongqing Municipality Recruiting
The first affiliated hospital of Chongqing Medical University Chongqing Chongqing Municipality Not Yet Recruiting
The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Not Yet Recruiting
Xinqiao Hospital of AMU Chongqing Chongqing Municipality Recruiting
Xinqiao Hospital Chongqing Chongqing Municipality Recruiting
Fujian Tumor Hospital Fuzhou Fujian Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Not Yet Recruiting
The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong Recruiting
The Sixth Affiliated Hospital of Sun Yat-Sen University Guangzhou Guangdong Recruiting
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong Not Yet Recruiting
Meizhou People's Hospital Meizhou Guangdong Recruiting
Shantou University Medical College Tumour Hospital Shantou Guangdong Recruiting
Guilin Medical College Second Affiliated Hospital Guilin Guangxi Recruiting
Guangxi Medical University Cancer Hospital Nanning Guangxi Recruiting
Guangxi Medical University Affiliated Tumour Hospital Nanning Guangxi Recruiting
The People's Hospital of Guangxi Nanning Guangxi Recruiting
Harbin Medical university cancer hospital Harbin Heilongjiang Recruiting
The First Affiliated Hospital Of Henan University&Technology Luoyang Henan Not Yet Recruiting
The First Affiliated Hospital of Nanyang Medical College Nanyang Henan Recruiting
Xinxiang Medical University No.1 Affiliated Hospital Xinxiang Henan Recruiting
He'nan Cancer Hospital South Gate Zhengzhou Henan Recruiting
Henan Provincial Chest Hospital Zhengzhou Henan Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
The First Peoples Hospital of Jingzhou Jingzhou Hubei Recruiting
Hubei Cancer Hospital Wuhan Hubei Recruiting
Tongji Hospital Wuhan Hubei Recruiting
Union Hospital Tongji Medical College HuaZhong University of Science Technology Wuhan Hubei Not Yet Recruiting
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology Wuhan Hubei Recruiting
Xiangyang Central Hospital Xiangyang Hubei Not Yet Recruiting
Hu'nan Province Cancer Hospital Changsha Hunan Recruiting
Hunan Provincial People's Hospital Changsha Hunan Recruiting
Xiangya hospital Central South University Changsha Hunan Recruiting
The Third People's Hospital of Hunan Province Yueyang Hunan Recruiting

+ 42 more sites — see the full list on the official registry below.

More MediLink Therapeutics (Suzhou) Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06107686 on ClinicalTrials.gov ↗ ← All trials in China