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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Solid Tumors With High Expression of Nectin4
• Intervention / Treatment: Diagnostic test: Immunohistochemistry

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-Nectin4 bicyclic peptide PET/CT imaging	Diagnostic test: Immunohistochemistry; Nectin4 Immunohistochemistry testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PET/CT imaging SuV value	0-45 minutes, 60 minutes

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytological Techniques; Histocytochemistry; Histological Techniques; Immunologic Techniques; Immunohistochemistry
• Other Study ID Numbers: 2025-68Ga-Nectin-4-peptide 02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No