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

NCT07815951 | Not Yet Recruiting Phase 1

• 1 other identifier: LYL2026266
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumors; Carcinoma; Ovarian Neoplasms; Endometrial Neoplasms Malignant; Testicular Neoplasms; Lung Neoplasms; Gastrointestinal Neoplasms

Keywords

Placental Alkaline Phosphatase; SPECT Imaging; 111In-TJD-31; Solid Tumor Diagnosis; radiation dosimetry; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 48 hours post-injection

• 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.

  Up to 48 hours post-injection

Secondary Outcomes (7)

• Incidence and Severity of Adverse Events and Serious Adverse Events

  Baseline through Day 7 post-injection

• Biodistribution of 111In-TJD-31 in Major Organs

  Up to 48 hours post-injection

• Number of Participants With Clinically Significant Changes in Vital Signs

  Baseline through Day 7 post-injection

• Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters

  Baseline through Day 7 post-injection

• Number of Participants With Clinically Significant Changes in Electrocardiography

  Baseline through Day 7 post-injection

Other Outcomes (5)

• Elimination Half-Life of 111In-TJD-31 in Healthy Volunteers

  0.5, 1, 4, 8, 24, and 48 hours post-injection

• Area Under the Plasma Concentration-Time Curve of 111In-TJD-31 in Healthy Volunteers

  0.5, 1, 4, 8, 24, and 48 hours post-injection

• Maximum Plasma Concentration of 111In-TJD-31 in Healthy Volunteers

  0.5, 1, 4, 8, 24, and 48 hours post-injection

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

Healthy volunteers receive a single intravenous injection of approximately 2 mCi (74 MBq) of 111In-TJD-31 Injection. Blood samples are collected at multiple time points (0.5, 1, 4, 8, 24, and 48 hours post-injection) for pharmacokinetic analysis. Safety follow-up is performed through Day 7 post-injection.

Drug: 111In-TJD-31 Injection

Patients with Malignant Solid Tumors

EXPERIMENTAL

Patients with confirmed malignant solid tumors receive a single intravenous injection of 3-5 mCi (111-185 MBq) of 111In-TJD-31 Injection. SPECT/CT whole-body planar imaging is performed at 4 ± 1 hours, 24 ± 2 hours, and 48 ± 2 hours post-injection, with tomographic imaging of regions of interest. Safety follow-up is performed through Day 7 post-injection.

Drug: 111In-TJD-31 Injection

Interventions

111In-TJD-31 Injection DRUG

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.

Healthy Volunteers; Patients with Malignant Solid Tumors

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Patients with Solid Tumors:
• 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;
• Life expectancy ≥6 months;
• Women of childbearing potential must have a negative pregnancy test, and all participants (including male participants) must agree to use effective contraception during the study period and for at least 3 months after study drug administration.
• For Healthy Volunteers:
• Chinese healthy volunteers, male or female;
• Age 18 to 55 years (inclusive);
• Body weight: females 45-80 kg (inclusive), males 50-80 kg (inclusive);
• Women of childbearing potential must have a negative pregnancy test, and all participants (including male participants) must agree to use effective contraception during the study period and for at least 3 months after study drug administration;
• Ability to communicate well with the investigator, understand and comply with all study requirements, and voluntarily sign informed consent before any study-related procedures.

You may not qualify if:

• For Patients with Solid Tumors:
• 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;
• 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;
• Active infection at screening;
• Unable to lie flat and still for at least 30 minutes during SPECT imaging, or having claustrophobia or other conditions that preclude SPECT imaging;
• Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.
• For Healthy Volunteers:
• 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;
• Clinically significant abnormalities in hematology, blood biochemistry, or urinalysis at screening;
• History of any clinically significant disease (including but not limited to cardiac, hepatic, renal, digestive, biliary, endocrine, cardiovascular, neurological, psychiatric, respiratory, immunological, hematological, hematopoietic, or urinary system disease) within 4 weeks prior to screening, as judged by the investigator;

Sponsors & Collaborators

• Yong He: lead
• Tuo Jiding (Jiaxing) Pharmaceutical Technology Co., Ltd.: collaborator

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Related Publications (6)

• Sgouros G, Bodei L, McDevitt MR, Nedrow JR. Radiopharmaceutical therapy in cancer: clinical advances and challenges. Nat Rev Drug Discov. 2020 Sep;19(9):589-608. doi: 10.1038/s41573-020-0073-9. Epub 2020 Jul 29.

  PMID: 32728208 BACKGROUND

• Kalofonos HP, Giannakenas C, Kosmas C, Apostolopoulos D, Onienadum A, Petsas T, Dimopoulos D, Epenetos AA, Vassilakos PJ. Radioimmunoscintigraphy in patients with ovarian cancer. Acta Oncol. 1999;38(5):629-34. doi: 10.1080/028418699431230.

  PMID: 10427953 BACKGROUND

• Yang Y, Wang K, Li W, Adelstein SJ, Kassis AI. Human placental alkaline phosphatase-mediated hydrolysis correlates tightly with the electrostatic contribution from tail group. Chem Biol Drug Des. 2011 Dec;78(6):923-31. doi: 10.1111/j.1747-0285.2011.01238.x. Epub 2011 Oct 24.

  PMID: 21910833 BACKGROUND

• Basiri M, Pahlavanneshan S. Evaluation of Placental Alkaline Phosphatase Expression as A Potential Target of Solid Tumors Immunotherapy by Using Gene and Protein Expression Repositories. Cell J. 2021 Nov;23(6):717-721. doi: 10.22074/cellj.2021.7299. Epub 2021 Nov 23.

  PMID: 34939766 BACKGROUND

• Mariani G, Bruselli L, Kuwert T, Kim EE, Flotats A, Israel O, Dondi M, Watanabe N. A review on the clinical uses of SPECT/CT. Eur J Nucl Med Mol Imaging. 2010 Oct;37(10):1959-85. doi: 10.1007/s00259-010-1390-8. Epub 2010 Feb 25.

  PMID: 20182712 BACKGROUND

• Juweid ME, Al-Qasem SF, Khuri FR, Gallamini A, Lohmann P, Ziellenbach HJ, Mottaghy FM. Beyond fluorodeoxyglucose: Molecular imaging of cancer in precision medicine. CA Cancer J Clin. 2025 May-Jun;75(3):226-242. doi: 10.3322/caac.70007. Epub 2025 Apr 4.

  PMID: 40183513 BACKGROUND

MeSH Terms

Conditions

Carcinoma; Ovarian Neoplasms; Endometrial Neoplasms; Testicular Neoplasms; Lung Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Yong He, MD, PhD

CONTACT

027-67812837; heyong@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Nuclear Medicine, Zhongnan Hospital of Wuhan University

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: September 11, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)