Phase
Condition
Neoplasms
Treatment
YL201
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Informed of the study before the start of the study and voluntarily sign theirname and date on the informed consent form (ICF).
Subjects will be enrolled in the dose-escalation phase: Advanced solid tumors,like NPC, SCLC and etc.
Subjects will be enrolled in the dose-expansion phase: NPC, SCLC, NSCLC and otheradvanced cancer.
According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1,there must be at least one extracranial measurable lesion.
Archived or fresh tumor tissue samples can be provided. 6) Within 7 days beforethe first dose, organ and bone marrow functions must meet the requirements.
Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1by the United States of America standards.
Female subjects of childbearing potential must agree to use highly effectivecontraception measures from screening throughout the duration of the study and forat least 6 months after the last dose of the study drug. Male subjects must agree touse highly effective contraception measures from screening throughout the durationof the study and for at least 6 months after the last dose of the study drug.
Subjects with expected survival ≥ 3 months. 10) Capable and willing to complywith the study protocol's scheduled visits and procedures.
Exclusion
Exclusion Criteria:
- Suitable for local radical treatment. 2) Previous Drug therapy targeting B7H3. 3)Previous Drug therapy with topoisomerase I inhibitors or ADCs composed oftopoisomerase I inhibitors.
Prior treatment with anti-PD-(L)1, other immune checkpoint inhibitors, immunecheckpoint agonists, or immunocellular therapies and other therapies targeting tumorimmunity mechanisms.
Toxicity from previous anticancer treatments has not resolved. 6) Concurrentenrollment in another clinical study. 7) Inadequate washout period for prioranticancer treatment before the first dose of study drug.
Underwent major surgery (excluding diagnostic surgery) or suffered serioustrauma.
Received allogeneic stem cell or solid organ transplant. 10) Active autoimmunediseases requiring systemic treatment. 11) Received systemic steroids. 12)Metastases to meninges or carcinomatous meningitis. 13) Brain metastasis or spinalcord compression. 14) Uncontrolled or clinically significant cardiovascular disease.
Clinically significant concomitant pulmonary disease. 16) With uncontrolledthird-space fluid. 17) History of gastrointestinal perforation and / or fistulawithin 6 months prior to the first dose.
Serious Infection prior to the first dose. 19) Known human immunodeficiencyvirus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Any other primary malignancy before the first dose of study drug. 21) A historyof severe hypersensitivity reactions to the investigational product, inactiveingredients in the formulation, or other monoclonal antibodies.
Women who are breastfeeding or pregnant as confirmed by pregnancy testsperformed within 3 days before the first dose.
Any illness, medical condition, organ system dysfunction, or social situation.
Study Design
Connect with a study center
Peking University Cancer Hospital
Beijing, Beijing Municipality
ChinaSite Not Available
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijinig
ChinaSite Not Available
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
ChinaSite Not Available
Fujian Provincial Cancer Hospital
Fuzhou, Fujian
ChinaSite Not Available
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
ChinaSite Not Available
The First Hospital of Lanzhou University
Lanzhou, Gansu
ChinaSite Not Available
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong
ChinaSite Not Available
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi
ChinaSite Not Available
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi
ChinaSite Not Available
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
ChinaSite Not Available
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
ChinaSite Not Available
Hubei Provincial Cancer Hospital
Wuhan, Hubei
ChinaSite Not Available
Union Hospital Tongji Medical College HuaZhong University of Science Technology
Wuhan, Hubei
ChinaSite Not Available
Hunan Cancer Hospital
Changsha, Hunan
ChinaSite Not Available
Jiangxi Cancer Hospital
Nanchang, Jiangxi
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
ChinaSite Not Available
The First Hospital of Jilin University
Changhua, Jilin
ChinaSite Not Available
Liaoning Provincial Cancer Hospital
Shenyang, Liaoning
ChinaSite Not Available
Shandong Cancer Hospital and Institute
Jinan, Shandong
ChinaSite Not Available
Linyi Central Hospital
Linyi, Shandong
ChinaSite Not Available
Zaozhuang Municipal Hospital
Zaozhuang, Shandong
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, Sichuan
ChinaSite Not Available
West China Hospital, Sichuan University
Sichuan, Sichuan
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
ChinaSite Not Available
Zhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang
ChinaSite Not Available
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
ChinaSite Not Available

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