TF-antigen Targeting Molecular Probe for PET Imaging in Solid Tumors

NCT ID: NCT06755086

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2026-12-31

Brief Summary

The objective of the study is to construct a noninvasive approach using 124I-labeled monoclonal antibody radiotracer to detect the Thomsen-Friedenreich antigen (TF-antigen, CD176) expression of tumor lesions in patients with solid tumors and to identify patients benefiting from TF-antigen targeting treatment.

Detailed Description

Analysis plan: 1. Recruit 3-5 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution, and tumor uptake information via whole-body PET/CT imaging; 2. Recruit 20 participants to analyze in vivo safety and tumor targeting information; 3. Recruit all participants for a final summary.

Conditions

Solid Tumors

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

124I-hJAA-F11

All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 124I-hJAA-F11 PET/CT scan.

18-FDG

Intervention Type: DRUG

All study participants will undergo one 18F-FDG PET/ CT scan.

Interventions

18-FDG

All study participants will undergo one 18F-FDG PET/ CT scan.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 and ≤ 75 years, male or female;

2. ECOG performance status score of 0 or 1;

3. Expected survival time ≥ 6 months;

4. At least one measurable tumor lesion exists according to RECIST 1.1 criteria (e.g., lung cancer, gastric cancer, colorectal cancer, breast cancer, pancreatic cancer, hepatocellular carcinoma). The lesion must be eligible for biopsy within one month before or after a PET scan, and the patient must be able to provide 2-3 tissue slices of the lesion;

5. Subjects must fully understand and voluntarily agree to participate in the study and sign an informed consent form.

Exclusion Criteria

1. Pregnant or breastfeeding women, or women planning to become pregnant during the study period or within three months after drug administration, as well as individuals donating sperm or eggs;

2. Individuals known or suspected to be allergic to the investigational drug or any of its components;

3. Individuals with significantly impaired liver or kidney function;

4. Individuals unable to comply with PET examinations or those with conditions such as claustrophobia that prevent them from undergoing PET scans.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Hua Zhu

Role: CONTACT

zhuhuabch@pku.edu.cn

010-88196495

Zhi Yang

Role: CONTACT

pekyz@163.com

010-88196196

Facility Contacts

Hua Zhu

Role: primary

zhuhuabch@pku.edu.cn

010-88196495

Other Identifiers

2024YJZ123

Identifier Type: -

Identifier Source: org_study_id