A Phase 1 interventional study of 111In-TJD-31 Injection in Solid Tumors, Carcinoma and Ovarian Neoplasms, sponsored by Yong He. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Yong He · Phase 1, Interventional, and Diagnostic
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.
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.
736 studies on the registry are indexed under Carcinoma; 149 are open to participants now.
This study's planned enrollment of 8 is below the median of 49 across 571 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Yong He is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For Patients with Solid Tumors:
For Healthy Volunteers:
Exclusion Criteria:
For Patients with Solid Tumors:
For Healthy Volunteers:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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.
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.
Time frame: 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.
Time frame: Up to 48 hours post-injection
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 48 hours 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.
Time frame: 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
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.
Time frame: 0.5, 1, 4, 8, 24, and 48 hours post-injection
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.
Time frame: 0.5, 1, 4, 8, 24, and 48 hours post-injection
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.
Time frame: 0.5, 1, 4, 8, 24, and 48 hours post-injection
Volume of Distribution of 111In-TJD-31 in Healthy Volunteers
Blood samples will be collected from healthy volunteers at multiple time points post-injection. Volume of distribution (Vd) will be determined using WinNonlin or equivalent software.
Time frame: 0.5, 1, 4, 8, 24, and 48 hours post-injection
Plan to share: No
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 70 phase 1 interventional studies under Carcinoma, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 92. This study's planned 12 months is below that.
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