Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18 - 75
Clinical summary
Summary
Eligible participants will receive the study drug (called SHR-A1904).
The study is assessing how safe and tolerable SHR-A1904 is in people with advanced solid cancer, and is aiming to determine the dose-limiting toxicity (DLT), maximum toleraed dose (MTD), and recommended phase II dose (RP2D) of SHR-A1904.
Eligibility
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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Scientific Title
An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Solid Tumors
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