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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: 18-FDG

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Zhi Yang; Phone Number: 010-88196196; Email: pekyz@163.com
• Study Contact Backup: Name: Hua Zhu; Phone Number: 010-88196495; Email: zhuhuaBCH@pku.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
      • Contact: Hua Zhu; Phone Number: 010-88196495; Email: zhuhuaBCH@pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Malignant tumor patients or suspected patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: 18-FDG; All study participants will undergo one 18F-FDG PET/ CT scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized uptake value（SUV）	SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions. The uptake of the tracer （124I-hJAA-F11） in solid tumor lesions by measuring SUV on PET/CT.	2 years

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Estimated): January 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 24, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Solid Tumors; PET imaging; TF-antigen; CD176
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 2024YJZ123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No