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Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors | Clinical Trials | Clareo Health

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Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors

A Study Evaluating the Safety, Pharmacokinetics, and Radiation Dosimetry of 68Ga/177Lu-BRP-020063 in Patients With Advanced Metastatic Solid Tumors.

NCT07439120•Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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);
+1 more criteria

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;
+5 more criteria

Key Dates

Start Date

March 2, 2026

Primary Completion Date

August 31, 2026

Completion Date

August 31, 2026

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Urothelial Carcinoma (UC)

Interventions

⁶⁸Ga/¹⁷⁷Lu-BRP-020063

DRUG

Contacts

Yan Xing, Dr.

CONTACT

+862163246311 xy.1@163.com

Korean Prospective Upper Tract Urothelial Carcinoma Cohort

NCT07452432

Urothelial Carcinoma (UC)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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