Actively Recruiting
A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy 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
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetics of SIBP-A18, an investigational drug, in patients with advanced solid tumors. The study aims to determine the maximum tolerable dose and recommended dose for further research, while also preliminarily assessing its anti-tumor effects and impact on heart electrical activity in this patient group. This is a phase I clinical trial sponsored by the Shanghai Institute Of Biological Products. The study consists of three stages involving multiple dose groups ranging from 1.0 to 8.0 mg/kg. Participants receive SIBP-A18 by intravenous infusion once every 21 days. The first stage focuses on dose escalation using an accelerated or traditional 3+3 method. The second stage expands dosing to enroll 6-9 participants per dose group, and the third stage explores the recommended dose in three specific cancer cohorts with at least 30 participants each. Participants will be monitored for adverse events, drug levels in the blood, and other pharmacokinetic measures at defined intervals up to 63 days after the first dose. Researchers will also assess tumor response, disease control, progression-free survival, and overall survival approximately 6 weeks after the last evaluation. Safety evaluations continue from the first dose through 28 days after the final dose, ensuring close follow-up during treatment.
CONDITIONS
Brief 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 tumor by histology or cytology
- For dose escalation and expansion: failed, intolerant, or no standard treatment available
- For indication expansion: CLDN18.2 positive late stage gastric, pancreatic, or biliary tract cancer with treatment failure or intolerance
- Willing and able to provide fresh or archived tumor tissue samples within 2 years
- At least one measurable lesion per RECIST v1.1 criteria
- No prior topoisomerase I inhibitor treatments including antibody drug conjugates
- ECOG performance status of 0 or 1
- Expected survival time of at least 3 months
- Normal major organ function without recent medical support
- Women of childbearing potential must have negative pregnancy test and agree to use effective contraception during and 6 months after the trial
- Voluntarily agree to participate and provide 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 only if stable and no recent treatment or symptoms
- Recent use of certain traditional Chinese medicines or anti-tumor treatments
- Adjuvant therapy within 6 months after surgery
- Unrecovered toxicity from prior anti-tumor treatment above grade 1 (except hair loss)
- Major surgery, radiation, biological therapy, or chemotherapy within 4 weeks prior to first dose
- Planned other anti-tumor treatments during trial (with some exceptions)
- Use of immunosuppressive agents or corticosteroids at immunosuppressive doses within 1 week prior
- Abnormal coagulation or recent significant blood loss or donation
- History of immunodeficiency, HIV, or organ transplantation
- Neurological or psychiatric disorders including epilepsy or dementia
- Active hepatitis B or C, except stable or cured cases
- Symptomatic effusions requiring drainage or recent serous cavity drainage
- Severe, progressive, or uncontrolled diseases increasing study risk
- Severe allergies to protein products or investigational drug components
- Pregnant or breastfeeding women
- Any other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies by participant depending on dose escalation and expansion stages
Participants receive intravenous SIBP-A18 injections at escalating doses every 21 days to evaluate safety, tolerability, and preliminary efficacy. The treatment includes dose escalation, dose expansion, and indication expansion stages with varying dose groups and cohorts.
1 visit every 21 days for each treatment cycle
Duration - Up to 28 days after last dose
Participants are monitored for adverse events and treatment outcomes for up to 28 days after the last dose, including assessments of efficacy and survival.
Follow-up visits as scheduled up to 28 days post-treatment
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
B
Bin Wu, Bachelor
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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