Safety Study of 177Lu-Anti-ED-B mAbs SPECT Imaging in Patients With ED-B Positive Solid Tumors

NCT ID: NCT05623891

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2023-12-31

Brief Summary

This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled anti-ED-B mAbs SPECT imaging in patients with ED-B positive solid tumors.

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 177Lu-labeled anti-ED-B mAbs and will undergo SPECT/CT scanning to determine uptake of 177Lu-labeled anti-ED-B mAbs in tumor lesions and normal tissues and organs.

Conditions

Solid Tumor, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

177Lu-Anti-ED-B mAbs

Patients will receive a tracer (5 mg, IV) dose of 177Lu (10 mCi) labeled anti-ED-B mAbs(177Lu-B5-IgG4)

Group Type: EXPERIMENTAL

177Lu-B5-IgG4

Intervention Type: DRUG

177Lu-B5-IgG4 injection followed by SPECT scan

Interventions

177Lu-B5-IgG4

177Lu-B5-IgG4 injection followed by SPECT scan

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients voluntarily signed informed consent, and be able to complete the trial according to the requirement of the scheme;

2. Aged 18-75, male or female;

3. Patients diagnosed with solid tumors confirmed by histopathology ;

4. Patients with biopsy-proven fibronectin ED-B positive;

5. At least one measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);

6. ECOG score 0~2;

7. ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit.

8. 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 abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;

4. Patients with autoimmune diseases, including rheumatoid arthritis;

5. Inadequate control of arrhythmias, including atrial fibrillation;

6. Uncontrolled hypertension;

7. Patients with allergies or allergies to any component of the imaging agent or antibody;

8. Patients who cannot undergo PET/CT imaging scan;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Jiangnan University

OTHER

Sponsor Role: lead

Responsible Party

Chunjing Yu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Countries

China

Central Contacts

Chunjing Yu

Role: CONTACT

ycj_wxd1978@163.com

15312238622

Facility Contacts

Chunjing Yu

Role: primary

ycj_wxd1978@163.com

15312238622

Other Identifiers

LS2022026

Identifier Type: -

Identifier Source: org_study_id