Actively Recruiting
A Phase I Study of SSGJ-612 in Patients With Advanced Solid Tumors
Led by Shenyang Sunshine Pharmaceutical Co., LTD. · Updated on 2025-07-25
30
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSGJ-612 in patients with advanced malignant solid tumors expressing HER2.
CONDITIONS
Official Title
A Phase I Study of SSGJ-612 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and complete all study procedures with signed informed consent
- Age between 18 and 75 years at the time of consent
- Expected survival of at least 3 months
- ECOG performance status score of 0-1
- Diagnosed with locally advanced or metastatic malignant tumors that have failed standard treatment, are intolerant to it, or lack standard treatment options, and cannot undergo surgery or radical chemoradiotherapy
- Tumor tissue shows HER2 expression
- At least one measurable tumor lesion suitable for repeated measurement per RECIST v1.1 criteria
You will not qualify if you...
- Presence of brainstem, meninges, or spinal cord metastasis, or spinal cord compression
- Active central nervous system metastatic lesions
- Clinical symptoms or need for frequent drainage of pleural, pericardial effusion, or ascites (once a month or more)
- Primary or secondary immunodeficiency, including positive HIV test
- Known active tuberculosis or syphilis infection
- History of allogeneic organ or hematopoietic stem cell transplantation
- Use or planned use of live or attenuated vaccines within 4 weeks before first dose or during study
- Severe allergic reaction history to study drug components or antibodies
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Actively Recruiting
Research Team
J
Jun Yao, M.D.
CONTACT
C
Cai'e Wang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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