Actively Recruiting
A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes SIBP-A19 injection in people with advanced or metastatic solid tumors. The study aims to find the highest dose patients can tolerate and the best dose for further study, while also looking at early signs of anti-tumor effects and possible biomarkers. This Phase 1 open-label trial is conducted at multiple centers and includes participants without effective standard treatment options. The trial has three stages: dose escalation, dose expansion, and indication expansion. During dose escalation, participants receive increasing doses of SIBP-A19 ranging from 1.0 to 8.0 mg/kg given by intravenous infusion every 21 days to find the maximum tolerated dose. The dose expansion phase enrolls additional participants at selected doses to further evaluate safety and effects. In the indication expansion phase, the recommended Phase II dose is tested in specific tumor groups with at least 30 participants per group. Participants will be closely monitored with assessments including adverse events from the first dose through 28 days after the last dose, evaluations of dose-limiting toxicities, and pharmacokinetic measurements at multiple time points. Researchers will also assess tumor responses and survival outcomes about six weeks after final evaluations. Safety follow-up continues throughout the study to understand the treatment’s impact and identify an appropriate dose for future research.
CONDITIONS
Brief 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 range from 18 to 75 years old (including boundary values), regardless of gender.
- Voluntarily participate in this study and sign the informed consent form.
- Participants with advanced or metastatic solid tumors diagnosed by histology or cytology, without standard treatment, standard treatment failure, or intolerance.
- Willing and able to provide sufficient fresh collected or archived tumor tissue samples or provide testing reports from legitimate institutions that meet the requirements.
- There must be at least one measurable lesion as the target lesion.
- ECOG score 0-1.
- Expected survival time 3 months.
- During the screening period, the main organ functions were basically normal (no medical support such as blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14 days before the use of the investigational drug): Blood routine: Absolute value of neutrophils (NE #) 1.5 �d7 10 9/L, platelet (PLT) count 90 �d7 10 9/L, hemoglobin (HGB) 90 g/L.
- Women of childbearing age during the screening period who have a negative blood pregnancy test and are capable of reproduction (including male participants) have no pregnancy plan and voluntarily take effective contraceptive measures during the trial period and within 6 months after the last dose.
You will not qualify if you...
- Participants with other malignant tumors not cured within the past 5 years (excluding certain cured cancers).
- Participants with untreated central nervous system metastasis.
- Meningeal metastases.
- Brain metastases treated and stable by imaging for at least 4 weeks, off related treatments for over 2 weeks without symptoms can enroll.
- Patients who received anti-tumor treatments or surgery within specific timeframes before the trial start.
- Patients planning other anti-tumor treatments during the trial (except specific prostate cancer therapy).
- Use of immunosuppressive agents or corticosteroids at immunosuppressive doses within one week before the investigational drug.
- Abnormal coagulation or bleeding tendencies, recent blood donation over 400 mL within 2 months.
- History of immunodeficiency, including HIV positive 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 or conditions increasing risk or affecting study completion.
- Uncontrolled fluid build-up requiring drainage or recent drainage within 4 weeks.
- Need for folic acid supplements.
- History of severe allergies to protein or cell products related to the investigational drug.
- Pregnant or lactating women.
- Any other conditions deemed unsuitable by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive intravenous infusions of SIBP-A19 every 21 days, with doses escalating or expanding based on safety and tolerance.
1 visit every 21 days for treatment administration
Duration - Up to 28 days after the last dose for adverse events monitoring; additional assessments may continue for approximately 6 weeks after last evaluation
Participants are monitored for safety, tolerability, and preliminary efficacy after completing treatment cycles.
Approximately 2 to 3 visits post-treatment
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
W
Wen qing Chai
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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