Solid TumorsPhase 1NCT07815951
Safety and Diagnostic Performance of 111In-TJD-31 SPECT Imaging in Patients With Solid Tumors
A Phase 1 study testing 111In-TJD-31 Injection in people with Solid Tumors and Carcinoma, run by Yong He at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Solid Tumors, Carcinoma, Ovarian Neoplasms
- What is being tested?
- 111In-TJD-31 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to 31 Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Blood pressure >150/100 mmHg or <90/50 mmHg at screening;
- Use of any prescription or over-the-counter medication (including herbal medicines, dietary supplements, and vitamins, except for routine continuous vitamin use) within 2 weeks prior to study drug administration, unless judged by the investigator as not affecting the study results;
- Blood donation or blood loss ≥500 mL within 12 weeks prior to study drug administration;
- History of any malignant tumor;
- 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 volunteer unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Yong He, MD, PhD, 027-67812837, heyong@whu.edu.cn
About this study
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
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.
Read the detailed description
Background and Rationale Malignant tumors remain a leading cause of mortality worldwide. Receptor-ligand-based radionuclide molecular imaging plays an increasingly important role in oncological diagnosis and therapy. Placental alkaline phosphatase (ALPP) is a classic "oncofetal antigen" with strict tissue specificity. It is highly expressed in placental trophoblasts during pregnancy but is virtually absent in most healthy adult tissues. Many studies have shown that ALPP is overexpressed in various malignant solid tumors, including germ cell tumors, ovarian cancer, endometrial cancer, and subsets of lung and gastrointestinal cancers. Its dense distribution on tumor cell membranes combined with low background in normal tissues provides a high target-to-noise ratio, making ALPP a promising target for molecular imaging and therapy.
Molecular Characteristics of TJD-31 TJD-31 is a fully humanized IgG1 monoclonal antibody probe developed to specifically target ALPP. It exhibits picomolar affinity (EC50 = 0.012 nM), excellent homologous specificity with no cross-reactivity to other alkaline phosphatase isoforms, rapid receptor-mediated endocytosis (over 80% internalization within 3 hours), and robust physicochemical stability under harsh conditions, supporting reliable radiolabeling and clinical application.
Study Objectives Primary Objective: To evaluate the lesion detection efficacy of 111In-TJD-31 SPECT/CT imaging in patients with malignant solid tumors.
Secondary Objectives: To characterize the safety, biodistribution, and radiation dosimetry of 111In-TJD-31 in patients.
Exploratory Objective: To explore pharmacokinetic characteristics in healthy volunteers.
Study Design This is an exploratory, prospective, open-label clinical study conducted at the Department of Nuclear Medicine, Zhongnan Hospital of Wuhan University. A total of 8 participants will be enrolled sequentially: 2 healthy volunteers and 6 patients with histologically confirmed malignant solid tumors.
Key Inclusion Criteria (for patients):
Voluntary written informed consent before any study-specific procedures; Clinically highly suspected or histologically/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. Imaging Protocol for Patients Patients will receive a single intravenous dose of 111In-TJD-31 (3-5 mCi). Whole-body planar SPECT/CT imaging will be performed at 4 ± 1 hours, 24 ± 2 hours, and 48 ± 2 hours post-injection, with tomographic imaging of the head/neck, torso, and known tumor lesions.
Pharmacokinetic Protocol for Healthy Volunteers Healthy volunteers will receive a single intravenous dose of approximately 2 mCi. Blood samples will be collected at 0.5, 1, 4, 8, 24, and 48 hours post-injection.
Safety Follow-up All participants will return for a safety visit on Day 7 (±1 day) post-injection, including vital signs, laboratory tests, and electrocardiography. Adverse events and serious adverse events will be recorded from injection through the follow-up period. Healthy volunteers will complete the study after the Day 7 assessment if no further monitoring is required.
The study has been approved by the Medical Ethics Committee of Zhongnan Hospital of Wuhan University.
- Conditions
- Solid Tumors, Carcinoma, Ovarian Neoplasms, Endometrial Neoplasms Malignant, Testicular Neoplasms, Lung Neoplasms
- Being tested
- 111In-TJD-31 Injection
- Keywords
- Placental Alkaline Phosphatase, SPECT Imaging, 111In-TJD-31, Solid Tumor Diagnosis, radiation dosimetry, pharmacokinetics
- Medical subject headings
- Carcinoma, Ovarian Neoplasms, Endometrial Neoplasms, Testicular Neoplasms, Lung Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
111In-TJD-31 InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 111In-TJD-31 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 48 hours post-injection
Secondary outcomes (7)
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.
Measured: Baseline 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.
Measured: Up to 48 hours 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.
Measured: Baseline 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.
Measured: Baseline through Day 7 post-injection
Number of Participants With Clinically Significant Changes in Electrocardiography
Number of participants with clinically significant changes from baseline in electrocardiography parameters assessed from dosing through Day 7 post-injection.
Measured: Baseline through Day 7 post-injection
Organ Absorbed Dose of 111In-TJD-31
Organ absorbed doses (mGy/MBq) will be estimated from serial SPECT/CT imaging data using OLINDA software. Regions of interest will be drawn for major source organs to determine time-integrated activity coefficients.
Measured: Up to 48 hours post-injection
Whole-Body Effective Dose of 111In-TJD-31
Whole-body effective dose (mSv/MBq) will be estimated from serial SPECT/CT imaging data using OLINDA software.
Measured: Up to 48 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yong He
- Sponsor type
- University, hospital or other
- Collaborators
- Tuo Jiding (Jiaxing) Pharmaceutical Technology Co., Ltd.
- Responsible party
- Sponsor-investigator, Yong He, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815951
- Sponsor's protocol ID
- LYL2026266
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32728208Kalofonos 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.
PubMed 10427953Yang 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.
PubMed 21910833Basiri 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.
PubMed 34939766Mariani 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.
PubMed 20182712Juweid 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.
PubMed 40183513