Actively Recruiting
A Study Evaluating the Safety, Pharmacokinetics, and Radiation Dosimetry of 68Ga/177Lu-BRP-020063 in Patients With Advanced Metastatic Solid Tumors
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-06-03
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, pharmacokinetics, biodistribution, and radiation dosimetry of the investigational drug 68Ga/177Lu-BRP-020063 in patients with advanced metastatic solid tumors, with a focus on urothelial carcinoma and breast cancer. This early-phase, open-label, single-arm trial also aims to preliminarily explore the therapeutic effects of this drug. The study plans to enroll 10 patients for PET/CT imaging and select 5 patients with positive imaging results for treatment with a low dose of the investigational drug. Participants will first receive a diagnostic phase involving a single intravenous injection of 68Ga-BRP-020063 followed by PET/CT scans. Those who test positive will then receive a therapeutic phase consisting of a single intravenous infusion of 177Lu-BRP-020063 over about 20 minutes. The doses are carefully controlled within specified ranges and followed by saline flushes. This approach will help researchers understand drug behavior and safety before considering higher doses in future studies. During the trial, patients will be closely monitored for adverse events from enrollment to four weeks after the first dose. Researchers will assess pharmacokinetics, biodistribution, and radiation dosimetry for up to 168 hours after administration. Participants will undergo imaging, laboratory tests, and safety evaluations throughout the study. The total participation duration covers initial diagnostic imaging, treatment, and follow-up safety monitoring to gather comprehensive data on the investigational drug's impact.
CONDITIONS
Brief Title
Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Confirmed diagnosis of advanced metastatic solid tumor, preferably urothelial carcinoma or breast cancer
- Willing to provide archived or recent tumor tissue samples
- Performance status (ECOG) score of 0 or 1
- Adequate organ function including blood counts, liver and kidney function, and coagulation parameters
- Females of childbearing potential must agree to use effective contraception during treatment and for 6 months after
- Willing to participate and sign informed consent
You will not qualify if you...
- Previous treatment with Nectin-4-targeted drugs
- Unable to complete PET/CT or SPECT/CT scans due to physical or psychological reasons
- Participation in other drug or device clinical studies within 4 weeks before the first dose
- Severe or uncontrolled underlying diseases such as heart failure, arrhythmia, cardiovascular or cerebrovascular conditions, poorly controlled diabetes or hypertension
- Unable to tolerate intravenous administration or difficulty with venipuncture
- Active infection within 4 weeks before the first dose
- Women who are pregnant, breastfeeding, or planning pregnancy
- Allergy to radioactive substances or history of severe allergic reactions
- History of symptomatic neurological metastasis
- Presence of other active cancers
- General anesthesia surgery within 4 weeks before the first dose
- Other conditions deemed unsuitable by the investigator for study participation
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.
Duration - Up to 4 weeks including imaging and treatment administration
Participants receive a single diagnostic injection of 68Ga-BRP-020063 followed by imaging. Those with positive imaging results receive a single therapeutic infusion of 177Lu-BRP-020063.
1 diagnostic injection visit plus 1 therapeutic infusion visit for selected participants
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China
Actively Recruiting
Research Team
Y
Yan Xing, 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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