Actively Recruiting
A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors
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
Primary Objectives Dose escalation phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the maximum tolerated dose (MTD), extended recommended dose (DRDE), and/or dose limiting toxicity (DLT). Dose expansion phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the recommended Phase 2 dose (RP2D). Clinical exploration phase To evaluate the preliminary efficacy of IBD0333 in patients with specific tumor. Secondary objectives Dose escalation phase \& Dose expansion phase To evaluate the pharmacokinetic (PK) of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the immunogenicity of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma. Clinical exploration Phase To evaluate the safety and tolerability of IBD0333 in patients with specific tumor; To evaluate the immunogenicity of IBD0333 in patients with specific tumor. Exploratory Objectives To explore biomarkers in blood and tissue that predict potential efficacy of IBD0333.
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
CONTACT
J
Jinming Yu, M.D.
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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