Actively Recruiting
A Clinical Trial of SIBP-A19 Injection in the Treatment of Advanced Malignant Solid Tumor Patients
Led by Shanghai Institute Of Biological Products · Updated on 2026-01-08
156
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A19 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
CONDITIONS
Official Title
A Clinical Trial of SIBP-A19 Injection in the Treatment of Advanced Malignant Solid Tumor Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Willing to voluntarily participate and sign informed consent
- Diagnosed with advanced or metastatic solid tumors by histology or cytology
- No available standard treatment, or standard treatment failed or intolerant
- Able and willing to provide fresh or archived tumor tissue samples or test reports
- At least one measurable tumor lesion
- ECOG performance status of 0 or 1
- Expected survival time of at least 3 months
- Normal main organ functions without recent medical support within 14 days before investigational drug use
- Adequate blood counts: neutrophils ≥ 1.5 x 10⁹/L, platelets ≥ 90 x 10⁹/L, hemoglobin ≥ 90 g/L
- Women of childbearing potential and men agree to effective contraception during the study and for 6 months after last dose, with negative pregnancy test
You will not qualify if you...
- Other malignant tumors not cured within past 5 years except certain cured cancers
- Untreated central nervous system metastases or meningeal metastases
- Unstable brain metastases unless stable for at least 4 weeks without symptoms
- Use of traditional Chinese patent medicines with anti-tumor effects within 2 weeks before first dose
- Adjuvant therapy within 6 months after surgery
- Unresolved toxicities from prior anti-tumor treatments above grade 1 (excluding hair loss)
- Major surgery, radiation, biological therapy, or chemotherapy within 4 weeks before first dose
- Planned anti-tumor treatments during trial except testosterone lowering therapy for prostate cancer
- Use of immunosuppressive agents or systemic corticosteroids with immunosuppressive dose within 1 week before investigational drug
- Abnormal coagulation, bleeding tendency, recent blood loss or donation over 400 mL within 2 months
- History of immunodeficiency including positive HIV or organ transplantation
- History of neurological or psychiatric disorders including epilepsy or dementia
- Known drug abuse, alcoholism, or drug use affecting trial results
- Serious uncontrolled diseases posing increased risk or affecting study completion
- Uncontrolled ascites, pleural or pericardial effusions requiring drainage
- Need for folic acid supplements
- Severe allergies to protein products, CHO cell products, recombinant antibodies, or investigational drug components
- Pregnant or lactating women
- Other reasons deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Union Hospital affiliated to Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
Research Team
D
Dan dan Chen, Master
CONTACT
W
Wen qing Chai
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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