Actively Recruiting
A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2024-06-21
133
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
CONDITIONS
Official Title
A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Advanced or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or no standard treatment is available
- At least one measurable tumor lesion based on RECIST v1.1 criteria
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- Expected survival period of at least 3 months
- Adequate organ function
- Agreement to use one medically approved contraceptive method
- Voluntary participation with signed informed consent
You will not qualify if you...
- Known central nervous system metastasis or hepatic encephalopathy
- Peripheral neuropathy
- History of significant lung diseases such as interstitial pneumonia, pneumonitis, pulmonary fibrosis, or severe radiation pneumonitis, or suspicion of these based on screening imaging
- Active, known, or suspected autoimmune disorders
- Known severe allergic reactions to any monoclonal antibodies
- Symptomatic ascites or pleural effusion requiring drainage, or drainage within 2 weeks before first dose
- Other malignancies currently or within the past 5 years
- Uncontrolled cardiac diseases or symptoms
- Known bleeding disorders or clotting tendencies
- Other factors that may affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
X
Xin Shi
CONTACT
W
Wenjie Xin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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