Clinical Trial · NCT07815951

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

Overview

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.

Sponsor

Zhongnan Hospital

Phase

Phase 1

Contacts

Yong He, MD, PhD (CONTACT)

heyong@whu.edu.cn

027-67812837

ClinicalTrials.gov

NCT07815951

Drug / Compound

TJD-31

Isotope(s):

Target(s):

Placental alkaline phosphatase

Ligand Class: Antibodies

Eligibility

Inclusion

Clinically highly suspected or histologically (or cytologically) confirmed malignant solid tumors with measurable lesions (target lesions), including treatment-naïve and relapsed patients;
For Patients with Solid Tumors:

Exclusion

Clinically significant abnormalities in hematology, blood biochemistry, or urinalysis at screening;
Significant hepatic or renal dysfunction: serum total bilirubin \>1.5 × upper limit of normal (ULN), or AST and/or ALT \>2.5 × ULN, or serum creatinine \>1.5 × ULN;