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

Prior treatment

• 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;

Other illness

• 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.

Lab values

• 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:

Other

• Clinically significant abnormalities in hematology, blood biochemistry, or urinalysis at screening;
• Blood pressure \>150/100 mmHg or \<90/50 mmHg at screening;

• 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.