Urothelial Carcinoma (UC)
Conditions
Brief summary
This study is an open-label, single-arm, interventional clinical trial designed to investigate the safety of ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 in patients with advanced metastatic solid tumors; to evaluate the pharmacokinetics, biodistribution, and radiation dosimetry of ¹⁷⁷Lu-BRP-020063 in patients with metastatic solid tumors; and to preliminarily explore its therapeutic efficacy. The study plans to enroll 10 patients to receive ⁶⁸Ga-BRP-020063 PET/CT imaging, among whom 5 patients positive for ⁶⁸Ga-BRP-020063 will be selected to receive a low dose of ¹⁷⁷Lu-BRP-020063. The results of this study will provide a basis for the design of subsequent studies involving higher doses of ¹⁷⁷Lu-BRP-020063.
Interventions
DRUG⁶⁸Ga/¹⁷⁷Lu-BRP-020063
68Ga-BRP-020063 Injection (Diagnostic Phase): All subjects will receive a single administration of 68Ga-BRP-020063 injection. The dose of 5 mCi (185 MBq), within an acceptable range of 3-7 mCi (111-259 MBq), will be delivered via rapid consecutive intravenous bolus injection in a volume not exceeding 10 mL, followed by a saline flush. 177Lu-BRP-020063 Injection (Therapeutic Phase): Five subjects who show positive results on the 68Ga-BRP-020063 PET/CT scan will be selected to receive a single administration of 177Lu-BRP-020063 injection. A dose of 40 mCi (1.48 GBq), within an acceptable range of 30-50 mCi (1.11-1.85 GBq), will be administered via intravenous infusion over approximately 20 minutes using an infusion pump, followed by a saline flush.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years, regardless of gender; 2. Patients with a confirmed diagnosis of advanced metastatic solid tumor (preferably urothelial carcinoma, followed by breast cancer); 3. Willing to provide archived or freshly biopsied tumor tissue specimens (recommended within the past 2 years); 4. Performance status (ECOG) score of 0-1; 5. Adequate organ function: * Complete Blood Count: White blood cell count ≥ 3.0 × 10⁹/L, neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/L, platelet count ≥ 75 × 10⁹/L; * Liver function: Total bilirubin ≤ 2.5 × ULN, alanine aminotransferase ≤ 3 × ULN, aspartate aminotransferase ≤ 3 × ULN; * Renal function: Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula); * Coagulation function: Prothrombin time ≤ 1.5 × ULN, activated partial thromboplastin time ≤ 1.5 × ULN, international normalized ratio ≤ 1.5 × ULN; 6. Subjects of childbearing potential must voluntarily adopt effective contraception during the treatment period and for 6 months after the last dose of the investigational drug (for females); 7. Willing to participate in this trial and sign an informed consent form.
Exclusion criteria
1. Previous treatment with Nectin-4-targeted drugs (including clinical trials); 2. Inability to complete PET/CT or SPECT/CT examinations (including inability to lie flat, claustrophobia, radiophobia, etc.); 3. Participation in drug or device clinical studies within 4 weeks prior to the first dose; 4. Presence of severe or uncontrolled underlying diseases, including but not limited to: 1. NYHA Class II or higher congestive heart failure, or severe arrhythmia requiring medication; 2. Severe cardiovascular/cerebrovascular or valvular diseases; 3. Poorly controlled diabetes or hypertension; 5. Inability to tolerate intravenous administration or difficulty with venipuncture (e.g., history of needle or blood phobia); 6. Active infection within 4 weeks prior to the first dose; 7. Women who are planning pregnancy, currently pregnant, or breastfeeding; 8. Allergy to radioactive rays or other severe allergic history; 9. History of neurological metastasis with associated symptoms; 10. Concurrent other malignancies; 11. Undergone general anesthesia surgery within 4 weeks prior to the first dose; 12. Other conditions deemed by the investigator as unsuitable for inclusion in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adeverse Events | From enrolment to 4 weeks after the first dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Parameters | From administration up to 168 hours post-dose | AUC(0-∞) |
| Biodistribution | From administration up to 168 hours post-dose | Perform whole-body SPECT/CT to determine radioactivity (%ID) in major organs over time for biodistribution assessment. |
| Radiation Dosimetry | from administration up to 168 hours post-dose | — |
Countries
China
Contacts
CONTACTYan Xing, Dr.
Outcome results
None listed