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

NCT07439120 | Recruiting Early Phase 1

• 1 other identifier: IIT-2026-030
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Adeverse Events

  From enrolment to 4 weeks after the first dose

Secondary Outcomes (3)

• PK Parameters

  From administration up to 168 hours post-dose

• Biodistribution

  From administration up to 168 hours post-dose

• Radiation Dosimetry

  from administration up to 168 hours post-dose

Other Outcomes (2)

• ORR

  be assessed at 6-week or 8-week intervals from the start of treatment until disease progression to up to 1 year.

• DCR

  be assessed at 6-week or 8-week intervals from the start of treatment until disease progression to up to 1 year.

Study Arms (1)

⁶⁸Ga/¹⁷⁷Lu-BRP-020063 Treatment Arm

EXPERIMENTAL

Drug: ⁶⁸Ga/¹⁷⁷Lu-BRP-020063

Interventions

⁶⁸Ga/¹⁷⁷Lu-BRP-020063 DRUG

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.

⁶⁸Ga/¹⁷⁷Lu-BRP-020063 Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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:
• 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;
• 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.

You may not qualify 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;
• 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;

Sponsors & Collaborators

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

Study Sites (1)

Shanghai General Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yan Xing, Dr.

CONTACT

+862163246311; xy.1@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 27, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)