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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: 18F-FDG

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhi Yang, Professor; Phone Number: 010-88196495; Email: pekyz@163.com
• Study Contact Backup: Name: Hua Zhu, Professor; Phone Number: 010-88196495; Email: zhuhuabch@pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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: 124I-EV; Imaging cohort All enrolled participants will be allocated to undergo three 124I-EV PET/CT scans.	Drug: 18F-FDG; All enrolled participants will be allocated to undergo one 18F-FDG PET/CT scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 3, 2022
• First Submitted That Met QC Criteria: April 3, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 2022KT25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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