Clinical Study of 68Ga-labeled Novel Nectin-4 Bicyclic Peptide PET/CT for Imaging of Solid Tumors With High Nectin-4 Expression

NCT ID: NCT07319130

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-03
• Study Completion Date: 2026-12-31

Brief Summary

Tumors are one of the major diseases threatening human health, among which solid tumors account for a considerable proportion. Nectin-4, as an important cell adhesion molecule, shows a highly expressed state in various solid tumors. In triple-negative breast cancer, the high expression rate of Nectin-4 can reach more than 50%, and it is closely associated with tumor invasion, metastasis and poor prognosis. Relevant studies have shown that the five-year survival rate of triple-negative breast cancer patients with high expression of Nectin-4 is significantly lower than that of patients with low expression. In urothelial carcinoma, the positive expression rate of Nectin-4 is also relatively high, reaching 40%-60%, and it is a highly potential target for tumor treatment and diagnosis. Its abnormal expression in solid tumors has opened up a new direction for the early diagnosis and targeted therapy of tumors. However, at present, the precise diagnosis and effective treatment of solid tumors with high expression of Nectin-4 still face many challenges. There is an urgent need for new technologies and methods to improve the diagnosis and treatment level in order to improve the prognosis of patients. Therefore, this study aims to develop a method targeting the Nectin4 bicyclic peptide to achieve non-invasive visualization of Nectin4 expression in tumors. This approach may also contribute to the formulation and optimization of clinical treatment strategies

Conditions

Solid Tumors With High Expression of Nectin4

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-Nectin4 bicyclic peptide PET/CT imaging

Group Type: EXPERIMENTAL

Immunohistochemistry

Intervention Type: DIAGNOSTIC_TEST

Nectin4 Immunohistochemistry testing

Interventions

Immunohistochemistry

Nectin4 Immunohistochemistry testing

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 1. Age: 18 to 75 years old (including the boundary value), gender not limited. 2. Solid tumors (such as urothelial carcinoma, breast cancer, lung cancer, etc.) that have been pathologically diagnosed with high expression of Nectin-4 within one month before imaging.

3. At least one evaluable tumor lesion (primary or metastatic) exists. 4. Voluntarily sign the informed consent form and be able to cooperate with the research process.

5.ECOG score: 0 to 2 points, expected survival period: ≥6 months.

Exclusion Criteria

• 1. Combined with other active malignant tumors (excluding non-melanoma skin cancer or carcinoma in situ).

2. Severe heart, liver and kidney insufficiency (such as ALT/AST >3 times ULN, creatinine clearance rate <30 mL/min).

3. Uncontrolled systemic infections or immune system diseases. 4. Pregnant or lactating women, or patients of childbearing age who have not taken effective contraceptive measures.

5. Previously received Nectin-4 targeted therapy (such as Enfortumab vedotin).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

2025-68Ga-Nectin-4-peptide 02

Identifier Type: -

Identifier Source: org_study_id