Actively Recruiting
A Study of BRY812 for Injection Alone in Subjects With Advanced Malignancies
Led by BioRay Pharmaceutical Co., Ltd. · Updated on 2025-12-30
164
Participants Needed
1
Research Sites
268 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 BRY812 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BRY812 for injection in patients with advanced malignancies. Patients will receive treatment every 3 weeks until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study.
CONDITIONS
Official Title
A Study of BRY812 for Injection Alone in Subjects With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who voluntarily sign informed consent and understand the study
- Male or female patients 18 years or older
- Patients with advanced solid tumors confirmed by histopathology or cytology who have failed or cannot tolerate standard treatments or have no effective standard treatment available
- At least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Adequate organ and bone marrow function, including neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 90 g/L, liver function within specified limits, and creatinine or creatinine clearance within specified limits
- Expected survival of at least 12 weeks
- Female subjects with fertility potential must test negative for serum human chorionic gonadotropin (HCG) before enrollment and agree to use effective contraception from consent to 6 months after last dose; males with female partners must also agree to use effective contraception
You will not qualify if you...
- Previous severe hypersensitivity to BRY812 or its components
- Prior treatment with drugs targeting LIV-1
- Active infections requiring intravenous treatment within 2 weeks before first dose
- Presence of two or more primary tumors (exceptions apply)
- Symptoms of active central nervous system metastases, except stable brain metastases meeting specific criteria
- Serious cardiovascular, cerebrovascular, or lung diseases as defined
- Active gastrointestinal bleeding or severe intestinal obstruction
- Major surgery within 4 weeks prior to first dose or planned during study
- History of allogeneic organ or hematopoietic stem cell transplantation
- Bleeding tendency or current thrombolytic or anticoagulant therapy
- Recent use of strong CYP3A4 or Pgp inhibitors or substrates, recent anti-tumor therapy or participation in other clinical studies
- Recent radiation therapy within specified timeframes
- Unresolved toxicity from previous cancer therapy greater than grade 1 (with exceptions)
- Recent live vaccination or plans for live vaccination during study
- Recent use of systemic corticosteroids or immunosuppressants, or history of active autoimmune disease
- Positive tests for certain infections including hepatitis B or C, HIV, or syphilis without appropriate management
- Mental or cognitive disorders limiting consent or study participation
- Pregnancy or breastfeeding
- Plans to donate sperm during study and for 6 months after last dose
- Other reasons assessed by investigator that may prevent study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here