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)
ORR assessed according to RECIST v1.1 — By the end of trial date, approximately within 36 months ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
Determination of the recommended dose of YL202 in the pivotal clinical study — By the end of trial date, approximately within 36 months
Trial sites (82)
Facility
City
Region
Status
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
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.
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