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

NCT05623891 | Unknown Early Phase 1

• 1 other identifier: LS2022026
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (3)

• Evaluation of tissue distribution of 177Lu-Anti-ED-B mAbs(B5-IgG4)

  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.

  1 year

• Dosimetry estimates of 177Lu-Anti-ED-B mAbs(B5-IgG4)

  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.

  1 year

• Incidence of Treatment-Emergent Adverse Events

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

  1 year

Study Arms (1)

177Lu-Anti-ED-B mAbs

EXPERIMENTAL

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

Interventions

177Lu-B5-IgG4 DRUG

177Lu-B5-IgG4 injection followed by SPECT scan

177Lu-Anti-ED-B mAbs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

Location

Central Study Contacts

Chunjing Yu

CONTACT

15312238622; ycj_wxd1978@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 21, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)