Actively Recruiting
Study of IBD0333 Safety, Dosage, and Early Effects in Advanced Solid Tumors and Non-Hodgkin Lymphoma
Led by SUNHO（China）BioPharmaceutical CO., Ltd. · Updated on 2025-01-17
48
Participants Needed
1
Research Sites
355 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and early effectiveness of a drug called IBD0333 in patients with locally advanced or metastatic solid tumors or non-Hodgkin lymphoma. This phase I/II trial includes dose-escalation, dose-expansion, and clinical exploration phases to determine the maximum tolerated dose, dose limiting toxicity, recommended phase 2 dose, and preliminary efficacy in specific tumors. The study also aims to explore biomarkers in blood and tissue that might predict how well IBD0333 works. The trial involves giving IBD0333 to participants in different phases: dose-escalation to find safe dose limits, dose-expansion to confirm safety and the recommended dose, and clinical exploration to study potential benefits in certain tumors. This open, non-randomized trial carefully monitors patients throughout these phases to evaluate the drug's effects. Participants will undergo regular assessments including tumor measurements according to RECIST 1.1 or Lugano 2014 criteria, laboratory tests to check organ function, and safety monitoring for adverse effects. The study measures maximum tolerated dose, dose limiting toxicity within 28 days after the first dose, recommended phase 2 dose, and overall response rate over about one year. Patients will also provide blood and tissue samples to study biomarkers, with informed consent required before participation.
CONDITIONS
Official Title
A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 18 and 80 years old
- Histologically or cytologically confirmed locally advanced/metastatic solid tumor or non-Hodgkin lymphoma with no effective standard therapy or intolerance to standard therapy
- At least one assessable tumor lesion in dose escalation phase or measurable lesion in dose expansion phase according to RECIST 1.1 or Lugano 2014
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate organ function shown by blood tests (specific blood counts, liver, kidney, and coagulation parameters)
- Agreement to use reliable contraception during the trial and for at least 120 days after stopping the investigational product (for patients of childbearing potential)
- Negative pregnancy test within 7 days before first dose (for female patients of childbearing potential)
- Investigator's assessment that patient could benefit from IBD0333
- Signed informed consent acknowledging investigational nature of treatment
You will not qualify if you...
- Known severe hypersensitivity to IBD0333 or its components
- Prior treatment with 4-1BB monoclonal antibody or related immune costimulatory agonists
- Recent anticancer therapies within specified timeframes before starting the investigational product (various chemotherapy, radiotherapy, biologic, endocrine, targeted, or immunotherapies)
- Use of investigational anticancer drugs within 4 weeks before starting the investigational product
- Major surgery or significant trauma within 4 weeks before starting investigational product, or planned surgery during trial
- Systemic corticosteroids or immunosuppressive medications within 14 days prior to starting investigational product (with some exceptions)
- Immunomodulatory treatments within 14 days before starting investigational product
- Live attenuated vaccinations within 4 weeks before starting investigational product
- History of allogeneic stem cell or organ transplant
- Unresolved adverse effects of prior anticancer treatments above grade 1
- Brain or meningeal metastases unless stable without progression for specified time
- Active infections needing intravenous therapy
- Immunodeficiency including HIV infection
- Active hepatitis B or C infection by defined lab criteria
- Interstitial lung disease except certain stable cases
- Serious cardiovascular diseases including severe arrhythmias, recent major events, heart failure class II-IV, or uncontrolled hypertension
- Previous or current autoimmune diseases except certain stable or mild conditions
- History of severe immune-related adverse events or myocarditis
- Other malignancies within last 2 years except certain treated cancers without evidence of disease
- Uncontrollable third interstitial fluid unsuitable for enrollment
- Alcohol or drug dependence
- Psychiatric disorders or poor compliance
- Pregnant or breastfeeding
- Serious systemic diseases or deemed unsuitable by investigator for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
N
Na Li
J
Jinming Yu, M.D.
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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