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Tests treatment safety and results for Urothelial Carcinoma (UC)
Official title Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07439120
What this study is testing
What is ⁶⁸Ga/¹⁷⁷Lu-BRP-020063?
⁶⁸Ga/¹⁷⁷Lu-BRP-020063 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for urothelial carcinoma (uc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years, regardless of gender;
- Patients with a confirmed diagnosis of advanced metastatic solid tumor (preferably urothelial carcinoma, followed by breast cancer);
- Willing to provide archived or freshly biopsied tumor tissue specimens (recommended within the past 2 years);
- Performance status (ECOG) score of 0-1;
- Adequate organ function:
You likely can't join if
- Previous treatment with Nectin-4-targeted drugs (including clinical trials);
- Inability to complete PET/CT or SPECT/CT examinations (including inability to lie flat, claustrophobia, radiophobia, etc.);
- Participation in drug or device clinical studies within 4 weeks prior to the first dose;
- Presence of severe or uncontrolled underlying diseases, including but not limited to:
- NYHA Class II or higher congestive heart failure, or severe arrhythmia requiring medication;
- Severe cardiovascular/cerebrovascular or valvular diseases;
See the full eligibility criteria
- Age ≥ 18 years, regardless of gender;
- Patients with a confirmed diagnosis of advanced metastatic solid tumor (preferably urothelial carcinoma, followed by breast cancer);
- Willing to provide archived or freshly biopsied tumor tissue specimens (recommended within the past 2 years);
- Performance status (ECOG) score of 0-1;
- 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;
- people 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);
- Willing to participate in this trial and sign an informed consent form.
- Previous treatment with Nectin-4-targeted drugs (including clinical trials);
- Inability to complete PET/CT or SPECT/CT examinations (including inability to lie flat, claustrophobia, radiophobia, etc.);
- Participation in drug or device clinical studies within 4 weeks prior to the first dose;
- Presence of severe or uncontrolled underlying diseases, including but not limited to:
- NYHA Class II or higher congestive heart failure, or severe arrhythmia requiring medication;
- Severe cardiovascular/cerebrovascular or valvular diseases;
- Poorly controlled diabetes or hypertension;
- Inability to tolerate intravenous administration or difficulty with venipuncture (e.g., history of needle or blood phobia);
- Active infection within 4 weeks prior to the first dose;
- Women who are planning pregnancy, currently pregnant, or breastfeeding;
- Allergy to radioactive rays or other severe allergic history;
- History of neurological metastasis with associated symptoms;
- Concurrent other malignancies;
- Undergone general anesthesia surgery within 4 weeks prior to the first dose;
- Other conditions deemed by the investigator as unsuitable for inclusion in the clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.