MMP14(MT1-MMP) Targeting Bicyclic Peptide Probe for PET Imaging in Solid Tumors

Analysis plan: 1. Recruit 3-5 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution, and tumor uptake information via whole-body PET/CT imaging; 2. Recruit 20-30 participants to analyze in vivo safety and tumor targeting information; 3. Recruit all participants for a final summary.

Inclusion criteria

• Malignant melanoma, glioma, lung cancer, colon cancer, pancreatic cancer, gastric cancer, breast cancer, liver cancer, etc., confirmed by histopathology or cytology;
• age ≥18 and ≤75 years old, male or female;
• ECOG score 0 or 1;
• expected survival time ≥6 months;
• There was at least one measurable target lesion according to RECIST1.1 criteria, and biopsy could be performed within one month before and after PET scan, and the patient could provide 2-3 lesion tissue slides;
• Women of childbearing age (15-49 years) must have had a negative pregnancy test within 7 days before starting testing; Women and men of childbearing potential must agree to use effective contraception to avoid pregnancy during the study and for 3 months after the examination;
• patients recommended by clinicians to undergo PET/CT examination for tumor staging;
• The subjects could fully understand and voluntarily participate in this experiment, and signed an informed consent.

Exclusion criteria

• Pregnant or breastfeeding women, or women planning to become pregnant during the study or within three months after administration, as well as individuals donating sperm or oocytes.
• Individuals known or suspected to be allergic to the investigational drug or any of its components.
• Individuals with significantly abnormal liver or kidney function: serum total bilirubin (TBIL) > 1.5 × 20 µmol/L, or aspartate aminotransferase (AST) > 2.5 × 45 µmol/L, or alanine aminotransferase (ALT) > 2.5 × 40 µmol/L, or serum creatinine > 1.5 × 130 µmol/L.
• Unable to cooperate in completing the PET scan, or suffering from claustrophobia or other conditions that prevent cooperation during the PET scan.
• Other situations deemed inappropriate for participation in the trial by the investigator. Female patients who are pregnant or breastfeeding.