Phase
Condition
Neoplasms
Treatment
YL201 for Injection
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed of the trial before the start of the trial and voluntarily sign their nameand date on the ICF.
Age ≥18 years old and ≤75 years old
Histologically or cytologically confirmed at diagnosis of NSCLC/SCLC/NPC/ESCC /mCRPC/HNSCC/Sarcoma/PDAC/HCC/BTC
At least one extracranial measurable lesion according to RECIST 1.1.
Archived or fresh tumor tissue samples can be provided.
Eastern Cooperative Oncology Group - performance scale (ECOG PS) score of 0 or 1.
Female subjects with fertility must agree to take high-efficiency contraceptivemeasures from screening to whole study period and within at least 6 months afterlast administration of investigational drug. Male subjects must agree to takehigh-efficiency contraceptive measures from screening to whole study period andwithin at least 6 months after last administration of investigational drug.
Life expectancy ≥3 months.
Capable or willing to observe the visits and procedures stipulated in studyprotocol.
Exclusion
Exclusion Criteria:
Prior treatment with products targeting B7H3 (including antibodies, antibody-drugconjugate [ADC], chimeric antigen receptor T cells [CAR-T], and other drugs).
Prior treatment with topoisomerase 1 inhibitors or ADC based on topoisomerase 1inhibitors.
Participation in another clinical trial meanwhile, except observatory (non-interventional) clinical trial or at follow-up period of interventional study.
Washout period of previous anticancer treatment was insufficient before firstadministration of investigational drug.
Major surgery (excluding diagnostic surgery) within 4 weeks before firstadministration of investigational drug or likely to require major surgery during thestudy.
History of allogenic bone marrow transplantation or solid organ transplantation.
Treatment with systemic steroid (Prednisone >10 mg/d or equivalent drugs) or otherimmunosuppressive drugs within 2 weeks before first administration ofinvestigational drug.
Live vaccination within 4 weeks before first administration of investigational drugor likely to require live vaccine inoculation during the study.
Evidence of leptomeningeal metastasis or carcinomatous meningitis.
Evidence of brain metastasis or spinal cord compression.
Evidence of cardiovascular disease with uncontrolled state or clinical significance.
Clinically significant concomitant lung disease.
Diagnosed as Gilbert syndrome.
Complicated with uncontrolled third-space effusion .
History of gastrointestinal perforation and/or fistula within 6 months before firstadministration.
History of serious infection (Grade ≥3 of NCI CTCAE) before first administration.
Known as infection with human immunodeficiency virus (HIV).
Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
History of any other primary malignant tumor within 5 years before firstadministration of investigational drug.
The toxicity of previous anticancer treatment is not resolved.
History of serious hypersensitive reactions to drug substance, inactive compositionsof preparations or other monoclonal antibodies.
Breastfeeding women. Or women confirmed as pregnant through pregnancy test within 3days before first administration.
Any disease, medical state, organ/system dysfunction or social state considered byinvestigators as possibly interfering the subject's capability for ICF signing,producing adverse influence on the subject's capability for cooperation and studyparticipation or influencing the interpretation of study results. Including but notlimited to mental disease or substance/alcohol abuse.
Study Design
Connect with a study center
Anhui Provincial Cancer Hospital
Hefei, Anhui
ChinaSite Not Available
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
ChinaActive - Recruiting
The First Affiliated Hospital of USTC
Hefei, Anhui
ChinaActive - Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui
ChinaActive - Recruiting
Peking University People's Hospital
Beijing, Beijing
ChinaActive - Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing
ChinaActive - Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
ChinaActive - Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
ChinaSite Not Available
Gansu Provincial Cancer Hospital
Lanzhou, Gansu
ChinaSite Not Available
Dongguan People's Hospital
Dongguan, Guangdong
ChinaActive - Recruiting
The Frist People's Hospital of Foshan
Foshan, Guangdong
ChinaActive - Recruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong
ChinaActive - Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
ChinaActive - Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510000
ChinaActive - Recruiting
Jiangmen Central Hospital
Jiangmen, Guangdong
ChinaActive - Recruiting
Yuebei People's Hospital
Shaoguan, Guangdong
ChinaActive - Recruiting
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong
ChinaActive - Recruiting
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
ChinaActive - Recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi
ChinaSite Not Available
Liuzhou Worker's Hospital
Liuzhou, Guangxi
ChinaActive - Recruiting
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi
ChinaActive - Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
ChinaActive - Recruiting
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan
ChinaActive - Recruiting
Affiliated Hospital of Chengde Medical University
Chengde, Hebei
ChinaSite Not Available
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang
ChinaActive - Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
ChinaSite Not Available
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
ChinaActive - Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
ChinaActive - Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
ChinaActive - Recruiting
Hunan Cancer Hospital
Changsha, Hunan
ChinaActive - Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
ChinaSite Not Available
The First People's Hospital of Changzhou
Changzhou, Jiangsu
ChinaActive - Recruiting
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu
ChinaSite Not Available
Nantong Tumor Hospital
Nantong, Jiangsu
ChinaSite Not Available
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu
ChinaActive - Recruiting
Jiangyin People's Hospital
Wuxi, Jiangsu
ChinaActive - Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu
ChinaSite Not Available
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi
ChinaActive - Recruiting
Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)
Nanchang, Jiangxi
ChinaActive - Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
ChinaActive - Recruiting
The First Hospital of Jilin University
Changchun, Jilin
ChinaSite Not Available
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning
ChinaSite Not Available
The Frist Hospital of China Medical University
Shenyang, Liaoning
ChinaSite Not Available
Binzhou Medical University Hospital
Binzhou, Shandong
ChinaSite Not Available
Shandong Cancer Hospital and Institute
Jinan, Shandong
ChinaActive - Recruiting
Shandong Provincial Hospital
Jinan, Shandong
ChinaSite Not Available
Linyi Cancer Hospital
Linyi, Shandong
ChinaActive - Recruiting
Shanxi Cancer Hospital
Datong, Shanxi
ChinaSite Not Available
The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
Xian, Shanxi
ChinaSite Not Available
Sichuan Cancer Hospital
Chengdu, Sichuan
ChinaActive - Recruiting
West China Hospital of Sichuan University
Huaxi, Sichuan
ChinaActive - Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
ChinaActive - Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
ChinaActive - Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
ChinaActive - Recruiting
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