Safety Study of 89Zr-NY001 PET Imaging in Patients

Safety Study of 89Zr-NY001 PET Imaging in Patients With Fibronectin ED-B Positive Solid Tumors

This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY001 (89Zr-NY001) PET imaging in patients with fibronectin ED-B domain positive solid tumors.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Diagnostic test: 89Zr-NY001

Detailed Description

After being fully informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of 89Zr-NY001 and will undergo PET/CT scanning to determine uptake of 89Zr-NY001 in tumor lesions and the whole body.

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

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Wuxi, Jiangsu, China, 214062
      • Wuxi No. 4 People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients voluntarily signed informed consent;
2. Aged >18, male or female;
3. Patients diagnosed with solid tumors confirmed by histopathology or cytology test;
4. At least two measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
5. Patients with biopsy-proven fibronectin ED-B positive;
6. ECOG score ≤ 0~3; Life expectancy of at least 3 months;
7. Women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects;
8. ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit;
9. Other routine examinations are within the normal range or considered acceptable by the researchers.

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with allergies or allergies to any component of the imaging agent or antibody;
4. Patients who cannot perform PET/CT imaging scan;
5. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
6. Patients with autoimmune diseases, including rheumatoid arthritis;
7. Inadequate control of arrhythmias, including atrial fibrillation;
8. Uncontrolled hypertension;
9. Syphilis, HBV, HCV, or HIV positive subjects;
10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
11. Pregnant or lactating women;
12. Patients with a history of mental illness or related conditions;
13. Other subjects considered unsuitable by researchers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 89Zr-NY001 injection; Patients will receive a tracer (5 mg, IV) dose of Zr-89 (1.5-2 mCi) labeled NY001 (89Zr-NY001)	Diagnostic test: 89Zr-NY001; 89Zr-NY001 injection followed by 89Zr-NY001 PET scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Focal lesion of 89Zr-NY001 PET scanning in patients with fibronectin ED-B domain positive solid tumors.	Degree and localization of focal lesion compared with that of 18F-FDG PET scans and according to the expression of fibronectin ED-B domain will be reported.	1 year

Collaborators and Investigators

• Sponsor: Wuxi No. 4 People's Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (ACTUAL): July 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Wuxi-4 PH NY001

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