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

NCT07439120 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Urothelial Carcinoma (UC)

Interventions

DRUG

⁶⁸Ga/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 & Collaborators

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

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-02
Primary Completion
2026-08-31
Completion
2026-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07439120 on ClinicalTrials.gov