Status:
ACTIVE_NOT_RECRUITING
A Study of SHR-A1904 in Patients With Advanced Solid Cancer
Lead Sponsor:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions:
Advanced Solid Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The study is being conducted to assess the safety and tolerability of SHR-A1904 in patients with advanced solid cancer and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), ...
Eligibility Criteria
Inclusion
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- Males or females aged 18-75 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Has a life expectancy≥ 3 months
- Has at least one measurable lesion as defined by RECIST v1.1
- Pathologically confirmed advanced solid cancer
Exclusion
- Plan to receive any other anti-tumor treatments during the study treatment period of this study
- Received other clinical investigational products or treatments within 4 weeks before the first dose of the study
- Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study
- Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the study
- Subjects with known brain metastases
- Grade II-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the study
- presence of accompanying diseases (such as poorly controlled hypertension, serious diabetes mellitus, thyroid disorder, psychosis, etc.) that may pose serious risks to the safety of the subject or may affect the subject's ability to complete the study, or any other situation as judged by the investigator
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT04877717
Start Date
July 1 2021
End Date
December 1 2025
Last Update
March 25 2025
Active Locations (1)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060