Actively Recruiting
A Phase I Study to Investigate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of BR111 for Injection in Patients With Advanced Malignancies
Led by BioRay Pharmaceutical Co., Ltd. · Updated on 2025-11-21
166
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase I, multicenter, open-label clinical trial to study BR111-101 for injection in patients with advanced cancers. This first-in-human study aims to assess the safety, tolerability, how the drug moves through the body, its anti-tumor effects, and immune response in patients whose cancers are advanced and have limited treatment options. The trial is sponsored by BioRay Pharmaceutical Co., Ltd. and focuses on patients with advanced solid tumors or relapsed/refractory B-cell lymphoma. BR111-101 will be given as an intravenous drip, with the first dose lasting at least 90 minutes and later doses possibly reduced to 30 minutes if well tolerated. The dose is based on body weight and may be adjusted depending on prior results. Treatment will continue until intolerable side effects, disease progression, pregnancy, withdrawal, death, or study discontinuation. The study includes a dose escalation phase to find the maximum tolerated dose and recommended dose for future studies. Participants will provide tumor samples for biomarker analysis and undergo regular assessments including safety monitoring, immune response tests, and tumor evaluations. Researchers will measure the maximum tolerated dose, recommended phase 2 dose, anti-drug antibodies, drug concentration, and objective response rates. The study duration for dose escalation is about 9 months, with follow-up for immune response continuing until 30 days after the last dose or if new cancer treatment starts. Participants will be closely monitored throughout the trial for safety and treatment effects.
CONDITIONS
Brief Title
A Study of BR111 in Patients With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to provide written informed consent
- Age 18 years or older, male or female
- Patients with histopathologically confirmed advanced solid tumors not suitable for surgery with failed or intolerant standard therapy
- Patients with relapsed/refractory B-cell lymphoma meeting 2016 WHO criteria and no other standard treatment
- Ability to provide tumor samples for biomarker analysis
- ECOG performance status of 0 to 1
- Life expectancy of 3 months or more
- Presence of at least one evaluable or measurable lesion according to RECIST v1.1 or Lugano 2014 criteria
- Adequate organ and bone marrow function
- Female patients of childbearing potential must have negative pregnancy test and agree to use effective contraception
- Ability to understand and comply with trial and follow-up requirements
You will not qualify if you...
- Unresolved toxicities from prior anticancer therapy above Grade 1 except alopecia or pigmentation
- Known severe allergy to BR111 or its components
- Previous treatment with eribulin or drugs targeting ROR1
- Primary central nervous system malignancy or active CNS invasion unless stable and asymptomatic
- Active infections requiring intravenous therapy within 14 days before first dose
- History or current interstitial lung disease or pneumonia requiring steroids
- Severe lung diseases affecting function or recent pneumonectomy
- Peripheral neuropathy Grade 2 or higher
- Serious cardiovascular or cerebrovascular diseases within 6 months before first dose
- Left ventricular ejection fraction less than 50%
- Prolonged QT interval over 470 ms on ECG
- Grade 3 or higher uncontrolled hypertension
- Significant bleeding or coagulation disorders
- Complete intestinal obstruction or symptomatic effusions
- Serious skin conditions prior to first dose
- Immunodeficiency or active autoimmune diseases requiring systemic steroids
- Other malignancies within 3 years except certain treated skin, bladder, prostate, cervical, or breast cancers
- Positive tests for HIV, syphilis requiring treatment, or certain hepatitis infections above thresholds
- Participation in other clinical trials within 4 weeks prior to first dose
- Major surgery or serious trauma within 4 weeks prior to first dose not fully recovered
- Recent anti-tumor therapies within specified time frames
- Recent hematopoietic stem cell or CAR-T cell transplantation within 3 months
- Mental or cognitive impairment limiting consent or 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
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 about 9 months or until discontinuation
Participants receive BR111 for Injection by intravenous drip in repeated cycles until intolerable toxicity, disease progression, withdrawal, or other specified reasons occur. Dosing frequency and interval may be adjusted based on prior data.
Multiple intravenous dosing visits; dosing duration is at least 90 minutes for the first dose and may be reduced to 30 minutes for subsequent doses
Duration - Up to 30 days after last dose
Participants are monitored for safety, immunogenicity, and treatment response after the last dose of BR111 until 30 days or until starting a new anti-cancer treatment.
1 to 2 visits depending on assessments
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
J
Jian Zhang, Doctoral Degree
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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