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NOT YET RECRUITING
NCT07815951
PHASE1

Safety and Diagnostic Performance of 111In-TJD-31 SPECT Imaging in Patients With Solid Tumors

Sponsor: Yong He

View on ClinicalTrials.gov

Summary

This study aims to evaluate the performance of a novel SPECT imaging agent, 111In-TJD-31, which targets placental alkaline phosphatase (ALPP). ALPP is a protein found on the surface of many malignant solid tumor cells but rarely present in healthy adult tissues. The purpose of this study is to assess the ability of 111In-TJD-31 to detect tumor lesions in patients with malignant solid tumors, as well as to evaluate its safety, biodistribution, pharmacokinetics, and radiation dosimetry. The study will enroll 8 participants: 2 healthy volunteers and 6 patients with confirmed malignant solid tumors. Healthy volunteers will provide blood samples at multiple time points after a single intravenous injection of 111In-TJD-31 to help measure how the agent moves through the body. Patients with malignant solid tumors will receive a single intravenous injection of 111In-TJD-31 and undergo SPECT/CT imaging at several time points post-injection. Participants will be followed for safety assessments through Day 7 after injection. This is an open-label, exploratory study conducted at Zhongnan Hospital of Wuhan University, with support from Tuo Jiding (Jiaxing) Pharmaceutical Technology Co., Ltd.

Official title: A Single-Arm, Open-Label, Exploratory Clinical Study to Evaluate the Safety, Biodistribution, Dosimetry, and Preliminary Diagnostic Performance of a Novel SPECT Tracer 111In-TJD-31 in Patients With Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2026-09

Completion Date

2027-12-31

Last Updated

2026-09-11

Healthy Volunteers

Yes

Interventions

DRUG

111In-TJD-31 Injection

111In-TJD-31 is a novel SPECT imaging tracer targeting placental alkaline phosphatase (ALPP). It is a fully humanized IgG1 monoclonal antibody probe radiolabeled with Indium-111. The injection is prepared by the Department of Nuclear Medicine, Zhongnan Hospital of Wuhan University, as an investigational agent and is not approved by any regulatory authority.

Locations (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China