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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05623891
Recruitment Status : Not yet recruiting
First Posted : November 21, 2022
Last Update Posted : November 23, 2022
Sponsor:
Information provided by (Responsible Party):
Chunjing Yu, Affiliated Hospital of Jiangnan University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: 177Lu-B5-IgG4 Early Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Arms and Interventions
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Arm Intervention/treatment
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)
 Drug: 177Lu-B5-IgG4
177Lu-B5-IgG4 injection followed by SPECT scan


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1 year ]
    Safety will be assessed by evaluation of incidence of adverse events.


Eligibility Criteria
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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
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Chunjing Yu 15312238622 ycj_wxd1978@163.com

Locations
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China, Jiangsu
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China, 214000
Contact: Chunjing Yu    15312238622    ycj_wxd1978@163.com   
Sponsors and Collaborators
Affiliated Hospital of Jiangnan University
More Information
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Responsible Party: Chunjing Yu, Director, Affiliated Hospital of Jiangnan University
ClinicalTrials.gov Identifier: NCT05623891    
Other Study ID Numbers: LS2022026
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms