Actively Recruiting
A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.
Led by Shanghai Institute Of Biological Products · Updated on 2026-01-07
144
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
Sponsors
S
Shanghai Institute Of Biological Products
Lead Sponsor
S
Shanghai Pulmonary Hospital, Shanghai, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
CONDITIONS
Official Title
A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 to 75 years old, any gender
- Diagnosed with locally advanced or metastatic solid tumors confirmed by histology or cytology
- For indication expansion stage, diagnosis of non-small cell lung cancer with EGFR mutation post treatment failure, HER3-positive breast cancer after standard treatment failure, or recurrent/metastatic advanced head and neck squamous cell carcinoma
- At least one measurable lesion according to RECIST v1.1 criteria
- No prior use of anti-HER3 antibodies or HER3-targeted therapies
- No prior treatment with topoisomerase I inhibitors including antibody drug conjugates
- ECOG performance status score of 0 or 1
- Expected survival time of at least 3 months
- Normal main organ functions without recent blood transfusion or medical support within 14 days before investigational drug
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and for 6 months after the study
- Willingness to voluntarily participate and sign informed consent
You will not qualify if you...
- History of other malignant tumors not cured within the past 5 years (except certain cured cancers)
- Untreated central nervous system metastasis or meningeal metastases
- Active brain metastases without stable imaging confirmation for at least 4 weeks after treatment cessation
- Recent use of traditional Chinese patent medicines with anti-tumor effects within 2 weeks before first dose
- Adjuvant therapy within 6 months after surgery
- Unrecovered toxicity from prior anti-tumor treatments above grade 1 (excluding hair loss)
- Major surgery, radiation, biological therapy, or chemotherapy within 4 weeks prior to first administration
- Plan to receive other anti-tumor treatments during the trial (except testosterone lowering therapy for prostate cancer)
- Use of immunosuppressive agents or corticosteroids at immunosuppressive doses within 1 week before investigational drug
- Abnormal coagulation or bleeding disorders, recent blood donation over 400 mL in 2 months
- History of immunodeficiency or organ transplantation
- Neurological or psychiatric disorders including epilepsy or dementia
- Positive syphilis test or active hepatitis B or C infections (except stable or cured cases)
- Symptomatic ascites, pleural or pericardial effusions requiring drainage within 4 weeks before first dose
- Severe, progressive, or uncontrolled diseases increasing risk or interfering with study completion
- Severe allergies to protein products, CHO cell products, or components of the investigational drug
- Pregnant or breastfeeding women
- Any other conditions judged unsuitable by researchers for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
D
Dandan Chen, Master
CONTACT
Y
Yanni Zhou, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here