Actively Recruiting
A Clinical Trial of SIBP-A17 Injection in the Treatment of Advanced Solid Tumor Patients.
Led by Shanghai Institute Of Biological Products · Updated on 2026-01-07
196
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A17 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
CONDITIONS
Official Title
A Clinical Trial of SIBP-A17 Injection in the Treatment of Advanced Solid Tumor Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old, any gender
- Diagnosis of advanced solid tumor confirmed by histology or cytology with no standard treatment or intolerance to standard treatment
- For dose expansion stage, specific cohorts of advanced breast, digestive system, gynecological tumors, or other HER2 positive solid tumors after standard treatment failure or intolerance
- Willing and able to provide fresh or archived tumor tissue samples during dose expansion
- At least one measurable lesion according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) score of 0 or expected survival of at least 3 months
- Normal main organ function without recent blood transfusion, G-CSF, or other medical support within 14 days before study drug use
- Negative pregnancy test for women of childbearing age and agreement to use effective contraception during study and for 6 months after last dose
- Voluntary participation and signed informed consent form
You will not qualify if you...
- Tumors specified as excluded in the protocol
- Previous treatments or surgeries as specified in the protocol during the trial period
- History of illnesses or abnormal lab findings specified in the protocol
- Positive Treponema pallidum antibody test or active hepatitis B or C infection
- Ascites, pleural or pericardial effusion requiring drainage or recent drainage within 4 weeks before first dose
- Severe, progressive, or uncontrolled diseases increasing risk to participant
- History or current interstitial lung disease or non-infectious pneumonia, or suspected cases not excluded by imaging
- Severe infections within 4 weeks or active infections treated with intravenous antibiotics within 2 weeks before first dose
- Participation in other clinical trials within 3 months before enrollment (excluding screening only)
- Severe concomitant diseases endangering safety or study completion
- History of severe allergies to protein products, CHO cell products, human or humanized antibodies, or study drug components
- Pregnant or lactating women
- Investigator judgment deeming participant unsuitable for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
D
Dandan Chen, Master
CONTACT
H
Hao Zhou, Bachelor
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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