Clinical trial NCT05623891: Safety Study of 177Lu-Anti-ED-B mAbs SPECT Imaging in Patients With ED-B Positive Solid Tumors
Official title: Safety Study of 177Lu-Anti-ED-B mAbs SPECT Imaging in Patients With ED-B Positive Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Solid Tumor, Adult
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Evaluation of tissue distribution of 177Lu-Anti-ED-B mAbs(B5-IgG4)
timeFrame: 1 year
measure: Dosimetry estimates of 177Lu-Anti-ED-B mAbs(B5-IgG4)
timeFrame: 1 year
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
Study officials:
References: