Actively Recruiting
A Study of BR111 in Patients With Advanced Malignancies
Led by BioRay Pharmaceutical Co., Ltd. · Updated on 2025-11-21
166
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR111-101 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR111-101 for injection in patients with advanced malignancies.
CONDITIONS
Official Title
A Study of BR111 in Patients With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to provide written informed consent
- Age 18 years or older, male or female
- Diagnosed with advanced solid tumors unresponsive to or intolerant of standard therapy or relapsed/refractory B-cell lymphoma with no standard treatment options
- Able to provide tumor samples for biomarker analysis at screening
- ECOG performance status of 0 to 1
- Life expectancy of at least 3 months
- Have at least one evaluable or measurable lesion according to RECIST v1.1 or Lugano 2014 criteria as applicable
- Adequate organ and bone marrow function
- Female patients of childbearing potential must have a negative pregnancy test and be non-lactating
- Patients and their partners willing to use effective contraception during the study and for 6 months after last dose
- Able to understand and comply with trial requirements and follow-up procedures
You will not qualify if you...
- Unresolved toxicities from previous anticancer therapy greater than Grade 1 except alopecia or pigmentation
- Severe allergy or delayed allergic reaction to BR111 or its components
- Prior use of eribulin or drugs targeting ROR1
- Primary CNS malignancy or active CNS invasion unless stable and asymptomatic for at least 4 weeks
- Active infections requiring intravenous therapy within 14 days before first dose
- History or current interstitial lung disease or pneumonia requiring steroid therapy
- Advanced tumor complications with dyspnea or need for continuous oxygen
- Moderate to severe lung diseases affecting lung function
- Peripheral neuropathy Grade 2 or higher
- Serious cardiovascular or cerebrovascular diseases within 6 months prior to first dose
- Left ventricular ejection fraction below 50%
- Prolonged QT interval in ECGs during screening
- Uncontrolled Grade 3 or higher hypertension
- Significant bleeding disorders or coagulation abnormalities
- Complete intestinal obstruction or symptomatic pericardial, pleural, or peritoneal effusions
- Serious skin conditions such as Stevens-Johnson syndrome or toxic epidermal necrolysis
- Immunodeficiency, active autoimmune diseases, or ongoing systemic steroid therapy above specified doses
- Other malignancies within 3 years except certain treated cancers
- Positive tests for HIV, active syphilis, hepatitis C, or hepatitis B with elevated viral load
- Participation in other clinical trial treatments within 4 weeks prior to first dose
- Major surgery or serious trauma within 4 weeks not fully recovered
- Recent anticancer therapies within specified timeframes prior to first dose
- Recent stem cell or organ transplantation or CAR-T therapy within 3 months
- Mental or cognitive impairments limiting consent or protocol compliance
- Other serious uncontrolled diseases or conditions posing risk as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Cancer
Shanghai, Pudong New Area, China, No. 4333, Kangxin Road
Actively Recruiting
Research Team
Z
Zhimin Shao, Doctoral Degree
CONTACT
J
Jian Zhang, Doctoral Degree
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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