Actively Recruiting
Phase I/II Study Evaluating Safety, Pharmacokinetics, and Preliminary Efficacy of IBD0333 in Patients With Advanced Solid Tumors or Non-Hodgkin Lymphoma
Led by SUNHO（China）BioPharmaceutical CO., Ltd. · Updated on 2025-01-17
48
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and preliminary effectiveness of a drug called IBD0333 in patients with locally advanced or metastatic solid tumors or non-Hodgkin lymphoma. The study includes dose escalation, dose expansion, and clinical exploration phases to find the best dose and explore how well the drug works in specific tumors. Additional goals include understanding how the drug behaves in the body and its immune effects, as well as exploring biomarkers that might predict response to treatment. This is an open, non-randomized phase I/II trial where patients receive IBD0333 during different study phases. The dose escalation phase determines the maximum tolerated dose and dose limiting toxicity over about one year. The dose expansion phase evaluates the recommended phase 2 dose and safety. During the clinical exploration phase, preliminary efficacy and immunogenicity are assessed. Treatment is given according to study protocols designed to evaluate safety and effectiveness. Participants will undergo regular assessments including monitoring for side effects, laboratory tests for organ function, imaging to evaluate tumor response, and blood tests to study drug levels and immune reactions. Researchers will track outcomes such as tumor response rate, duration of response, and progression-free survival over about one year. Safety and tolerability will be closely observed throughout the study. Total participation time may vary depending on individual treatment and follow-up schedules.
CONDITIONS
Brief 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 aged 18 to 80 years
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor or non-Hodgkin lymphoma
- Failed or intolerant to standard therapy or no standard therapy available
- At least one assessable tumor lesion (dose escalation) or measurable lesion (dose expansion) per 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 including blood counts, liver, kidney, and coagulation parameters
- Agree to use reliable contraception during the trial and for 120 days after discontinuation if of childbearing potential
- Negative pregnancy test within 7 days before first dose (for females of childbearing potential)
- Investigator assessment of potential benefit from IBD0333
- Signed informed consent document
You will not qualify if you...
- Known severe hypersensitivity to recombinant proteins or components of IBD0333
- History of 4-1BB monoclonal antibody or dual antibody immune costimulatory molecule agonist
- Recent anti-cancer therapies within specified timeframes before starting investigational product
- History of investigational anti-cancer drug within 4 weeks prior
- Major surgery or significant trauma within 4 weeks prior or planned selective surgery during trial
- Systemic corticosteroids or immunosuppressive medication within 14 days prior (except certain topical or short-term uses)
- Treatment with immunomodulatory agents within 14 days prior
- Live attenuated vaccine within 4 weeks prior
- History of allogeneic hematopoietic stem cell or organ transplantation
- Unresolved adverse effects from prior anticancer treatments above defined severity
- Brain or meningeal metastases without stable disease for required periods
- Active infections requiring intravenous therapy
- History of immunodeficiency including HIV positive status
- Active hepatitis B or C infection above defined levels
- Interstitial lung disease except stable pulmonary fibrosis without hormone therapy
- Serious cardiovascular disease including severe arrhythmias, heart failure, recent acute events
- Autoimmune diseases except certain stable conditions
- History of severe immune-related adverse events
- Other malignancies within 2 years except certain treated cancers
- Uncontrollable interstitial fluid unsuitable for enrollment
- Alcohol or drug dependence
- Psychiatric disorder or poor compliance
- Pregnant or breastfeeding
- Serious systemic disease or other conditions unsuitable for participation in the study
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 - Up to approximately 1 year
Participants receive IBD0333 to evaluate its safety, tolerability, pharmacokinetics, and preliminary efficacy for advanced solid tumors or non-Hodgkin lymphoma.
Visits scheduled according to dosing and safety monitoring during treatment
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
Frequently Asked Questions
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