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NCT05623891
Safety Study of 177Lu-Anti-ED-B mAbs SPECT Imaging in Patients With ED-B Positive Solid Tumors
Conditions: Solid Tumor, Adult
Sex: All
Ages: 18 Years – 75 Years
Phase: EARLY_PHASE1
Enrollment: 10
Sponsor: Affiliated Hospital of Jiangnan University
Location: China
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.
Eligibility Criteria
Inclusion Criteria:Patients voluntarily signed informed consent, and be able to complete the trial according to the requirement of the scheme;Aged 18-75, male or female;Patients diagnosed with solid tumors confirmed by histopathology ;Patients with biopsy-proven fibronectin ED-B positive;At least one measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);ECOG score 0~2;ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit.Other routine examinations are within the normal range or considered acceptable by the researchers.Exclusion Criteria:Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;Patients with systemic or locally severe infections, or other serious coexisting diseases;Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;Patients with autoimmune diseases, including rheumatoid arthritis;Inadequate control of arrhythmias, including atrial fibrillation;Uncontrolled hypertension;Patients with allergies or allergies to any component of the imaging agent or antibody;Patients who cannot undergo PET/CT imaging scan;Syphilis, HBV, HCV, or HIV positive subjects;Male and female subjects of reproductive age cannot take effective contraceptive measures;Pregnant or lactating women;Patients with a history of mental illness or related conditions;Other subjects considered unsuitable by researchers.
Source: ClinicalTrials.gov (NCT05623891). StuddyBuddy aggregates publicly available trial information.