Safety Study of 177Lu-Anti-ED-B mAbs SPECT Imaging in Patients With ED-B Positive Solid Tumors
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|ClinicalTrials.gov Identifier: NCT05623891|
Recruitment Status : Not yet recruiting
First Posted : November 21, 2022
Last Update Posted : November 23, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Adult||Drug: 177Lu-B5-IgG4||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety Study of 177Lu-Anti-ED-B mAbs SPECT Imaging in Patients With ED-B Positive Solid Tumors|
|Estimated Study Start Date :||December 2022|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: 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)
177Lu-B5-IgG4 injection followed by SPECT scan
- Evaluation of tissue distribution of 177Lu-Anti-ED-B mAbs(B5-IgG4) [ Time Frame: 1 year ]Biodistribution of 177Lu-Anti-ED-B mAbs(B5-IgG4) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 177Lu-SPECT scans will be reported.
- Dosimetry estimates of 177Lu-Anti-ED-B mAbs(B5-IgG4) [ Time Frame: 1 year ]Absorbed dose (radioactive uptake) estimates for different organs and tissues calculated with the AUCs and the OLINDA/EXM dosimetry program will be obtained and reported.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1 year ]Safety will be assessed by evaluation of incidence of adverse events.
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05623891
|Contact: Chunjing Yufirstname.lastname@example.org|
|Affiliated Hospital of Jiangnan University|
|Wuxi, Jiangsu, China, 214000|
|Contact: Chunjing Yu 15312238622 email@example.com|
|Responsible Party:||Chunjing Yu, Director, Affiliated Hospital of Jiangnan University|
|Other Study ID Numbers:||
|First Posted:||November 21, 2022 Key Record Dates|
|Last Update Posted:||November 23, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|