Actively Recruiting
A Phase I Clinical Study of the Safety, Tolerability and Efficacy of BRY812 for Injection in Patients With Advanced Malignancies
Led by BioRay Pharmaceutical Co., Ltd. · Updated on 2025-12-30
164
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BRY812 for injection in patients with advanced malignancies in this Phase I, multicenter, open-label, single-arm clinical study. The study aims to assess the safety, tolerability, how the drug moves through the body, its anti-tumor effects, and immune response in patients with advanced solid tumors who have not responded to or cannot tolerate standard treatments. This first-in-human trial is sponsored by BioRay Pharmaceutical Co., Ltd.
CONDITIONS
Brief Title
A Study of BRY812 for Injection Alone in Subjects With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study procedures
- Male or female patients aged 18 years or older
- Advanced solid tumors confirmed by histopathology or cytology, refractory or intolerant to standard treatments
- At least one measurable lesion by RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) status 0 to 1
- Adequate organ and bone marrow function as defined by specified blood counts and liver/kidney function
- Expected survival of at least 12 weeks
- Females of reproductive potential must have negative pregnancy test and agree to effective contraception; males with female partners must agree to contraception
You will not qualify if you...
- Known severe allergy to BRY812 or its components
- Previous treatment with drugs targeting LIV-1
- Active infections requiring intravenous therapy within 2 weeks before first dose
- Presence of two or more primary tumors (with specified exceptions)
- Active symptoms of central nervous system metastases unless stable as defined
- Serious cardiovascular, cerebrovascular, or lung diseases as specified
- Active gastrointestinal bleeding or severe intestinal blockage
- Major surgery within 4 weeks before first dose or planned during study
- History of organ or stem cell transplantation
- Bleeding disorders or use of blood thinners
- Recent use of certain drugs including anti-tumor therapies and strong CYP3A4/Pgp inhibitors
- Recent radiation therapy within specified timeframes
- Unresolved side effects from prior cancer therapies above grade 1 except specified exceptions
- Recent live vaccinations or planned live vaccines during study
- Recent use of systemic corticosteroids or immunosuppressants
- Positive tests for certain infections including hepatitis B or C, HIV, or untreated syphilis
- Mental or cognitive disorders limiting consent or study participation
- Pregnancy or breastfeeding
- Plans to donate sperm during study and 6 months after last dose
- Other conditions that may affect ability to complete the study as assessed 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 - Repeated 3-week cycles until intolerable toxicity, disease progression, withdrawal, or study discontinuation
Participants receive BRY812 for injection by intravenous drip once per 3-week cycle. Treatment continues until intolerable toxicity, disease progression, withdrawal, or other discontinuation criteria are met.
1 visit per cycle (in-person)
Duration - Up to approximately 3 years after last dose
Participants are monitored for safety and efficacy outcomes after the last dose of BRY812, including adverse events and survival assessments.
Visits as scheduled for up to 3 years post-treatment
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital，Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
H
He rui Yao, PhD
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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