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.
Voluntary signed written informed consent before any study-specific procedures;
Clinically highly suspected or histologically (or cytologically) confirmed malignant solid tumors with measurable lesions (target lesions), including treatment-naïve and relapsed patients;
Age ≥18 and ≤75 years, male or female;
ECOG performance status 0 or 1;
Pregnant or breastfeeding women, or women planning to become pregnant during the study period or within 3 months after study drug administration (except those who have been postmenopausal for at least 1 year or have undergone surgical sterilization such as bilateral tubal ligation without reversal, bilateral oophorectomy, or hysterectomy); or participants planning to donate sperm or eggs during the study period or within 3 months after study drug administration;
Known or suspected allergy to the study drug or any of its components;
Receipt of another investigational agent at enrollment, or within 5 half-lives or 30 days after the last dose of such agent, whichever is longer;
Use of any radiotherapeutic agent within 90 days prior to study drug administration, or use of any radionuclide diagnostic agent within 3 days prior to study drug administration;
Single group
111In-TJD-31 Injection
Drug111In-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.
Qualitative Assessment of Tumor Uptake by Visual Analysis
111In-TJD-31 SPECT/CT images will be independently reviewed by two experienced nuclear medicine physicians blinded to other clinical data. Positive tumor uptake is defined as focal or diffuse increased tracer accumulation above surrounding normal tissue, after excluding physiological uptake in normal organs and tissues.
Semi-Quantitative Assessment of Tumor Uptake Using Standardized Uptake Value
111In-TJD-31 SPECT/CT images will be reconstructed using the ordered subset expectation maximization method with attenuation and scatter correction. Regions of interest will be drawn around tumor lesions to calculate standardized uptake values (SUV) as a semi-quantitative measure of tracer accumulation.
Incidence and Severity of Adverse Events and Serious Adverse Events
Number of participants with adverse events and serious adverse events graded according to CTCAE v5.0 criteria from dosing through Day 7 post-injection.
Biodistribution of 111In-TJD-31 in Major Organs
Biodistribution of 111In-TJD-31 will be assessed using serial SPECT/CT images. Regions of interest will be drawn for major organs (liver, kidney, spleen, red marrow, urinary bladder, and whole-body background) to determine radioactive retention (%ID/g or %ID/organ) at multiple time points post-injection.
Number of Participants With Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes from baseline in vital signs, including temperature, pulse, respiration rate, and blood pressure, assessed from dosing through Day 7 post-injection.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Number of participants with clinically significant changes from baseline in hematology, urinalysis, liver function, renal function, and coagulation function tests assessed from dosing through Day 7 post-injection.
Elimination Half-Life of 111In-TJD-31 in Healthy Volunteers
Blood samples will be collected from healthy volunteers at multiple time points post-injection. Elimination half-life (t½) will be determined using WinNonlin or equivalent software.
Area Under the Plasma Concentration-Time Curve of 111In-TJD-31 in Healthy Volunteers
Blood samples will be collected from healthy volunteers at multiple time points post-injection. Area under the plasma concentration-time curve (AUC) will be determined using WinNonlin or equivalent software.
Maximum Plasma Concentration of 111In-TJD-31 in Healthy Volunteers
Blood samples will be collected from healthy volunteers at multiple time points post-injection. Maximum plasma concentration (Cmax) will be determined using WinNonlin or equivalent software.
Clearance of 111In-TJD-31 in Healthy Volunteers
Blood samples will be collected from healthy volunteers at multiple time points post-injection. Clearance (CL) will be determined using WinNonlin or equivalent software.
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Yong He
Lead sponsor
Zhongnan Hospital
Sponsor institution
Tuo Jiding (Jiaxing) Pharmaceutical Technology Co., Ltd.
Collaborator
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