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Clinical Study of 68Ga-Nectin-4 Bicyclic Peptide Combined with PET/CT for Imaging of Nectin-4 High-Expressing Solid Tumors

Clinical Study of 68Ga-Nectin-4 Bicyclic Peptide Combined with PET/CT for Imaging of Nectin-4 High-Expressing Solid Tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105713
Enrollment
Unknown
Registered
2025-07-09
Start date
2025-08-29
Completion date
Unknown
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor

Interventions

Experimental Group:Gallium [68Ga]-Nectin-4 Bicyclic Peptide Injection Combined with PET/CT Imaging

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 75 years (inclusive), regardless of gender; 2.Pathologically confirmed solid tumors with high Nectin-4 expression (e.g., urothelial carcinoma, breast cancer, lung cancer, etc.); 3.At least one assessable tumor lesion (primary or metastatic); 4.Voluntary signed informed consent and ability to cooperate with the study procedures. 5.ECOG performance status 0 to 2, with an expected survival of >=6 months;

Exclusion criteria

Exclusion criteria: 1. Combined with other active malignancies (except non-melanoma skin cancer or carcinoma in situ); 2. Severe cardiac, hepatic, and renal insufficiency (such as ALT/AST > 3 times ULN, creatinine clearance < 30 mL/min); 3. Uncontrolled systemic infection or immune system disease; 4. Pregnant or lactating females, or patients of childbearing age who do not take effective contraceptive measures; 5. Prior Nectin-4 targeted therapy (e.g., enfortumab vedotin).

Design outcomes

Primary

MeasureTime frame
Adverse events;Serious adverse events;

Secondary

MeasureTime frame
Biological distribution characteristics;Targeting Ability for Solid Tumors with High Nectin-4 Expression;

Countries

China

Contacts

Public ContactDeng Shengming

The First Affiliated Hospital of Soochow University

dshming@163.com+86 15051510189

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026