A Study of YL202 in Selected Patients With Advanced Solid Tumors

Recruiting · NCT06107686 · Interventional (participants receive a specific treatment) · Lead sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

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Breast Cancer

Interventions studied

YL202 should be intravenously infused

What this trial is about

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.

Who can take part

Age range

18 Years to 75 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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).
Subjects aged from 18-75 (inclusive) years.
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..
At least one extracranial measurable lesion according to RECIST 1.1.
Archived or fresh tumor tissue samples can be provided.
With Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
The function of organs and bone marrow meets the requirements within 7 days before the first dose.
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.
With expected survival ≥ 3 months.
Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.

Exclusion criteria

With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates \[ADCs\]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).
Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
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.
The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.
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.
Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
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.
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.
With meningeal metastasis or cancerous meningitis.
With brain metastasis or spinal cord compression.
Patients with uncontrolled or clinically significant cardiovascular diseases.
Clinically significant complicated pulmonary disorders.
Patients diagnosed with Gilbert syndrome.
Those with uncontrolled effusion in the third space requiring repeated drainage.
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.
With serious infection before the first dose.
With known human immunodeficiency virus (HIV) infection.
With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product.
Unrelieved toxicity of previous anti-tumor therapy.
With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies.
Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose.
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.

Where it is running

60 locations listed.

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

Showing 60 of 82 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →