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

Sponsor
Affiliated Hospital of Jiangnan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05623891
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
12
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Evaluation of tissue distribution of 177Lu-Anti-ED-B mAbs(B5-IgG4) [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) [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 [1 year]

    Safety will be assessed by evaluation of incidence of adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Affiliated Hospital of Jiangnan University Wuxi Jiangsu China 214000

Sponsors and Collaborators

  • Affiliated Hospital of Jiangnan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chunjing Yu, Director, Affiliated Hospital of Jiangnan University
ClinicalTrials.gov Identifier:
NCT05623891
Other Study ID Numbers:
  • LS2022026
First Posted:
Nov 21, 2022
Last Update Posted:
Nov 23, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Nov 23, 2022