Testing a New Scan Tracer, 111In-TJD-31, in People With Solid Tumors

Trial details

Who runs it

Yong He

Trial code

NCT07815951

Record updated

11 September 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: 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; 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; 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; 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; Known or suspected allergy to the study drug or any of its components; 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; 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:; Clinically significant abnormalities in hematology, blood biochemistry, or urinalysis at screening; Blood pressure >150/100 mmHg or <90/50 mmHg at screening.

ClinicalTrials.gov NCT07815951