A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging

Prior treatment

• Those who had received other investigational drugs at the time of enrollment, or were within 5 half-lives of the drug at the time of enrollment or within 4 weeks after the last administration, whichever is shorter; those who planned to participate in any clinical trial of drugs or devices during the trial period within 4 weeks before the administration of the test drug or within 3 half-lives after the last administration;
• Those who had received anti-angiogenic drugs within 4 weeks before the administration of the test drug or 3 half-lives (whichever is longer);
• Those who had previously used radioactive nuclides and the interval from the administration of this trial drug to the current time was less than 10 physical half-lives;
• Those who had undergone major surgery within 4 weeks before the administration of the test drug, or had undergone diagnostic surgery or invasive intervention within 7 days before the administration, or planned to have surgery and other invasive interventions within 2 days after the administration of the test drug;

Other illness

• Those known or suspected to be allergic to the test drug or any of its components;
• Those who cannot accept or tolerate blood sample collection and intravenous administration (if they have a history of fainting or hemophilia);
• Those with positive results for human immunodeficiency virus antibody, active syphilis (defined as positive syphilis antibody test and positive RPR test), or active hepatitis B (defined as hepatitis B virus [HBV] DNA ≥ 2000 IU/mL) or hepatitis C (defined as positive HCV RNA test);
• Those who had suffered from other malignant tumors within 2 years, except for skin basal cell carcinoma, skin non-metastatic superficial squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ;
• Those who had active infections requiring systemic anti-infective treatment at the time of screening;
• Those who cannot lie still and remain quiet for about 60 minutes in the PET examination cabin, or have claustrophobia or other conditions that prevent them from cooperating with the PET examination;
• Any severe diseases that are uncontrollable, such as severe cardiac dysfunction (such as unstable angina pectoris, myocardial infarction, heart failure, etc.), patients with large pleural effusion, patients with mental disorders, etc.;

Lab values

• Those with significantly abnormal liver and kidney functions: serum total bilirubin (TBIL) > 1.5 × ULN (upper limit of normal value), or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 × ULN, or serum creatinine > 1.5 × ULN;

Age

• Pregnant or lactating women, or women of childbearing age who tested positive for pregnancy during the screening period;

Other

• Other situations that the investigator deems as unsuitable for participating in this trial.

• Agree to comply with all the requirements and procedures of the clinical trial and voluntarily sign the informed consent form;
• Male or female patients aged 18 years or older at the time of signing the informed consent form;
• Diagnosed with soft tissue sarcoma by histopathology or cytology, and failed or were intolerant to at least one line of standard treatment, or had no standard treatment available, or refused to receive standard treatment;
• Have at least one measurable lesion (according to RECIST V1.1 standards, a measurable lesion is defined as: a non-lymph node lesion with the longest diameter ≥ 10mm or a lymph node lesion with the short diameter ≥ 15mm measured by CT or MRI);
• Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1;
• Female or male participants with reproductive capacity must not have any plans for pregnancy, egg donation or sperm donation from the date of signing the informed consent form until 3 months after the administration of the trial drug, and must agree to take effective contraception (including one or more non-drug contraceptive measures) or safety measures during this period.