Nectin-4 Targeting ADC Probe for PET Imaging in Solid Tumors

Solid Tumor Clinical Trial

Official title:

Nectin-4 Targeting ADC Probe for PET Imaging in Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05322512
• Other study ID #: 2022KT25
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: Zhi Yang, Professor
• Phone: 010-88196495
• Email: pekyz[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the normal physiological distribution of the probe 124I-EV in human body and its ability to detect overexpression of Nectin-4 in tumor lesions.

Description:

Nectin-4 is highly expressed in different types of cancer and is involved in various aspects of tumor proliferation, angiogenesis, metastasis, tumor recurrence, and DNA repair. Therefore, the development of nuclear medicine molecular probes targeting Nectin-4 is of great significance for improving the specificity and accuracy of Nectin-4 related cancer diagnosis.

EV (Enfortumab vedotin) is the first and only drug targeting Nectin-4 so far. By exploring the diagnostic efficacy of 124I-EV in tumors with high nectin-4 expression, it will not only provide evidence for the early diagnosis of tumors. At the same time, the Nectin-4 expression in tumors can be used to develop effective and precise treatment for patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18-75 years old, male or female;

2. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;

3. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.

4. Normal heart function;

5. Good follow-up compliance;

6. presence of at least one measurable target lesion according to RECIST1.1 criteria

7. Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before the start of the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test.

Exclusion Criteria:

1. Serious abnormality of liver, kidney and blood;

2. Pregnant patients;

3. Pregnant and lactation women;

3) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• 18F-FDG
All enrolled participants will be allocated to undergo one 18F-FDG PET/CT scan.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUV (Standardized Uptake Value)	SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions? The uptake of the tracer (124I-EV) in tumor lesions by measuring SUV on PET/CT.	2 years