Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors (NCT07439120) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors
10 participantsStarted 2026-03-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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:
✓. 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);
✓. Willing to participate in this trial and sign an informed consent form.
Exclusion criteria
✕. 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.);
What they're measuring
1
Adeverse Events
Timeframe: From enrolment to 4 weeks after the first dose
Trial details
NCT IDNCT07439120
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine