To hear about similar clinical trials, please enter your email below
Trial Title:
Safety Study of 177Lu-Anti-ED-B mAbs SPECT Imaging in Patients With ED-B Positive Solid Tumors
NCT ID:
NCT05623891
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
177Lu-B5-IgG4
Description:
177Lu-B5-IgG4 injection followed by SPECT scan
Arm group label:
177Lu-Anti-ED-B mAbs
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hospital of Jiangnan University
Address:
City:
Wuxi
Zip:
214000
Country:
China
Contact:
Last name:
Chunjing Yu
Phone:
15312238622
Email:
ycj_wxd1978@163.com
Start date:
December 2022
Completion date:
December 2023
Lead sponsor:
Agency:
Affiliated Hospital of Jiangnan University
Agency class:
Other
Source:
Affiliated Hospital of Jiangnan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05623891
