A Study of YL202 in Selected Patients With Advanced Solid Tumors
NCT ID: NCT06107686
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2023-12-15
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Corhort A
YL202 is provided as the lyophilized powder, 200 mg/vial. Locally advanced or metastatic NSCLC patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
YL202 should be intravenously infused
For each patient, YL202 should be intravenously infused over 60±10 min.
Corhort B
YL202 is provided as the lyophilized powder, 200 mg/vial. Locally advanced or metastatic BC patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
YL202 should be intravenously infused
For each patient, YL202 should be intravenously infused over 60±10 min.
Corhort C
YL202 is provided as the lyophilized powder, 200 mg/vial. Locally advanced or metastatic HNSCC patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
YL202 should be intravenously infused
For each patient, YL202 should be intravenously infused over 60±10 min.
Corhort D
YL202 is provided as the lyophilized powder, 200 mg/vial. Other locally advanced cancer patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
YL202 should be intravenously infused
For each patient, YL202 should be intravenously infused over 60±10 min.
Interventions
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YL202 should be intravenously infused
For each patient, YL202 should be intravenously infused over 60±10 min.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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MediLink Therapeutics (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
The Affiliated Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The No.10 Peoples Hospital
Shanghai, Shanghai Municipality, China
Shanxi Province Cancer Hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital Of Xi'an JiaoTong University
Xian, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
SiChuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
West China Hospital,Sichuan Universtiy
Chengdu, Sichuan, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Yunnan Tumor Hospital
Kunming, Yunnan, China
The Second Affiliated Hospital of Zhejiang University school of Medicine
Hangzhou, Zhejiang, China
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Province People's Hospital
Hangzhou, Zhejiang, China
Zhejiang Province People's Hospital
Hangzhou, Zhejiang, China
Zhejiang University Medical College Affiliated No.1 Hospital
Hangzhou, Zhejiang, China
Yiwu Central Hospital
Jinhua, Zhejiang, China
Taizhou Hospital of Zhejiang
Taizhou, Zhejiang, China
Countries
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Facility Contacts
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Other Identifiers
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YL202-CN-201-01
Identifier Type: -
Identifier Source: org_study_id
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