Actively Recruiting
A Clinical Trial of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients
Led by Shanghai Institute Of Biological Products · Updated on 2026-01-07
156
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A18 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D). A secondary purpose To preliminarily evaluate the anti-tumor efficacy of SIBP-A18. Evaluate the effect of SIBP-A18 injection on Q to T interval/Corrected QT interval (QT/QTc interval) in participants with advanced solid tumors
CONDITIONS
Official Title
A Clinical Trial of SIBP-A18 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 old, any gender
- Diagnosed with advanced solid tumors by histology or cytology
- For dose escalation and expansion: failed, intolerant to, or ineligible for standard treatment
- For indication expansion: CLDN18.2 positive late-stage gastric, pancreatic, or biliary tract cancer with failed, intolerant, or no standard treatment
- Willing and able to provide fresh or archived tumor tissue samples within 2 years
- At least one measurable target lesion by CT or MRI according to RECIST v1.1
- No prior treatment with topoisomerase I inhibitors, including antibody drug conjugates
- ECOG performance status 0 or 1
- Expected survival time of at least 3 months
- Normal main organ functions without recent medical support within 14 days before study drug
- Women of childbearing potential and male participants must use effective contraception during and for 6 months after the trial
- Voluntary participation and signed informed consent
You will not qualify if you...
- Other malignant tumors not cured within the past 5 years (except certain cured cancers)
- Untreated central nervous system metastases or meningeal metastases
- Brain metastases unless stable for at least 4 weeks and off related treatments without symptoms
- Recent use of anti-tumor treatments or surgery not recovered to normal toxicity levels
- Use of immunosuppressive agents or corticosteroids at immunosuppressive doses within 1 week before study drug
- Abnormal coagulation or recent significant blood loss/donation
- History of immunodeficiency or organ transplantation
- Neurological or psychiatric disorders including epilepsy or dementia
- Active infections with hepatitis B or C, except stable or cured cases
- Symptomatic ascites, pleural or pericardial effusion requiring drainage
- Severe or uncontrolled diseases increasing risk as judged by the investigator
- Severe allergies to protein products or components of the investigational drug
- Pregnant or breastfeeding women
- Any condition making participation unsafe or unsuitable per investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
D
Dandan Chen, Master
CONTACT
B
Bin Wu, 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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