Actively Recruiting
Phase I/II Study Evaluating BT02 Safety and Preliminary Anti-Tumor Effects in Adults with Advanced Solid Tumors
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-12-27
60
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an open-label, first-in-human Phase I/II study to evaluate BT02 in adults with advanced solid tumors. The study aims to assess the safety, how well patients tolerate BT02, how the drug moves through the body, immune response triggered by the drug, and initial signs of its effect against tumors. This trial includes patients diagnosed with advanced solid tumors confirmed by tissue analysis. Participants will receive BT02 monoclonal antibody injections as part of dose escalation cohorts, with an expected enrollment of 10 to 30 patients. The study is designed to determine the maximum tolerated dose and monitor dose-limiting toxicities. The treatment is given during the initial phase, and patient responses and safety are closely observed. Throughout the study, participants will undergo assessments to track adverse events, immune reactions, and tumor response using standardized criteria. Researchers will monitor safety and tolerability within 28 days after drug administration. Participants must be able to comply with follow-up visits and have measurable or evaluable tumor lesions. The total duration and specific schedules of visits or procedures are arranged to ensure comprehensive evaluation of BT02's effects and safety.
CONDITIONS
Official Title
Clinical Trial of BT02 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older at the time of signing the informed consent form, male or female
- Histologically or cytologically confirmed diagnosis of advanced solid tumor
- Adequate organ and blood function
- At least measurable or evaluable tumor lesion in Phase I and measurable lesion in Phase II per RECIST 1.1
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Ability and willingness to comply with follow-up visits
You will not qualify if you...
- Prior systemic anti-cancer therapy
- Active or documented autoimmune disease within the past 2 years
- History of significant cardiovascular disease
- Significant acute or chronic infections
- Residual toxicities from previous anti-cancer treatments not improved to Grade 3 severity
- Any prior Grade 3 or higher immune-related adverse event from immunotherapy
- Unstable brain or meningeal metastases with symptoms
- Mental disorders or poor compliance
- Known alcohol or drug abuse
- Other severe systemic diseases or conditions deemed unsuitable by the investigator
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Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital
Beijing, Biejing, China, 1000021
Actively Recruiting
Research Team
N
Ning Li, Dr
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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