Safety and tolerability of Ga-68/Lu-177 BRP-020063 in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm early-phase trial evaluating a radiopharmaceutical targeting solid tumors. The study first uses Ga-68 BRP-020063 PET/CT to assess tumor uptake and biodistribution, then, in a subset, administers a low dose of Lu-177 BRP-020063 to evaluate safety and preliminary efficacy. Key outcomes include safety/tolerability, pharmacokinetics, dosimetry, and any signs of therapeutic activity. Enrollment planned for 10 patients, with up to 5 receiving radioligand therapy after imaging confirmation. Results will inform the design of higher-dose studies moving forward.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai General Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Yan Xing, Dr.
• Email: xy.1@163.com
• Phone: +862163246311

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.