A Phase II Clinical Study Evaluating the Effectiveness of Injectable NC527-X in Intraoperative Imaging for Patients With Solid Tumors

Summary

Evaluate the initial dose-effect and time-effect relationship of the injection product NC527-X

Eligibility

Inclusion criteria:

1. 1\. Voluntarily sign a written informed consent form;
2. 2\. Male and female individuals aged 18 years or above;
3. 3\. Patients with solid tumors that have been diagnosed by imaging tests or confirmed by pathology and who are scheduled for surgical removal;
4. 4\. The ECOG score ranges from 0 to 1;
5. 5\. During the trial period, the subjects used effective contraceptive methods and continued to use contraception for another 3 months after the medication was completed.
6. 6\. Be able to understand the procedures and methods of this study, and be willing to strictly follow the clinical trial protocol and complete this trial.

Exclusion criteria:

1. 1\. Has a history of allergic reactions to similar products, contrast agents, or fluorescent lamps, or is known to be allergic to the study drug or any other components.
2. 2\. 28 days prior to the first administration, the subject had received a similar drug (such as indocyanine green for injection);
3. 3\. Within one month prior to the first administration, participants were enrolled in another clinical study (including observational or non-interventional clinical studies);
4. 4\. Within 28 days prior to the first administration, had received a live attenuated vaccine;
5. 5\. Within one month prior to the first administration, had undergone major surgical procedures (as defined by the investigators);
6. 6\. The subjects had previously undergone allogeneic stem cell or solid organ transplantation;
7. 7\. Within 28 days prior to the first administration, there were adverse reactions caused by previous treatments that had not recovered to grade 1 or below according to CTCAE 5.0 criteria (pigmentation, hair loss; adverse reactions that the investigator deemed safe can be included);
8. 8\. The laboratory test results during the screening period indicated that the subjects did not have good organ function: a. Hematology (Blood transfusion within 14 days before the screening laboratory tests and treatment with blood components or granulocyte colony-stimulating factor need to be excluded) i. Absolute neutrophil count \< 1.5 × 109/L (1,500/mm3); ii. Platelet count \< 75 × 109/L; iii. Hemoglobin \< 9.0 g/dL; b. Liver i. Serum total bilirubin (TBil) \> 1.5 × ULN; for subjects with liver metastasis or those with evidence of or suspected Gilbert's disease, TBil \> 3 × ULN; ii. AST and ALT \> 2.5 × ULN, for subjects with liver metastasis, AST and ALT \> 5 × ULN; c. Kidney: Serum creatinine \> 1.5 × ULN; or glomerular filtration rate estimated according to the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI formula, see Appendix 2) \< 60 mL/(min \* 1.73m2); d. Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) \> 1.5 × ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected range for anticoagulant treatment at the time of screening);
9. 9\. Patients with primary central nervous system tumors or those with symptomatic central nervous system metastases (meningeal metastases, regardless of whether they are symptomatic or not, must be excluded);
10. 10\. Within 6 months prior to the first administration of the drug, the following cardiovascular diseases occurred: symptomatic heart failure with a New York Heart Association (NYHA) classification of 2 or above (see Appendix 3), left ventricular ejection fraction (LVEF) \< 50%, unstable arrhythmia or unstable angina pectoris, myocardial infarction requiring treatment, pulmonary embolism, uncontrolled hypertension (this protocol defines uncontrolled hypertension as although the optimal antihypertensive treatment is adopted, but after treatment, systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg, and the investigator assesses it to have clinical significance). Note: Three 12-lead electrocardiograms indicating QTc interval prolongation \> 450 milliseconds (ms) (for males) or 470 ms (for females) must be excluded; For atrial fibrillation or paroxysmal supraventricular tachycardia that requires treatment but is assessed by the investigator to be stable, it can be considered for inclusion.
11. 11\. Within 4 weeks prior to the first administration of the drug, there was a history of severe infection or an active infection occurred within 2 weeks.
12. 12\. The following disease-infected individuals are present: Human Immunodeficiency Virus (HIV) infection; Active hepatitis B virus carriers \[Hepatitis B Surface Antigen (HBsAg) positive, and hepatitis B virus DNA (HBV-DNA) test result \> 200 IU/mL or 103 copies/mL\]; Hepatitis C virus carriers \[HCV antibody and viral RNA (HCV-RNA) test results are positive\]; Treponema pallidum antibody positive and RPR positive individuals;
13. 13\. Female subjects who have tested positive for pregnancy during the screening period, are currently breastfeeding, or plan to become pregnant or give birth during the course of this trial; Male subjects whose spouses have a pregnancy plan within the last 3 months.
14. 14\. Any other diseases, medical conditions or abnormalities, metabolic disorders, physical examination results, clinical laboratory test results that prohibit the use of the study drug, may affect the interpretation of the results, or may place the subjects at a high risk of treatment complications, or according to the investigator's judgment, are not suitable for using the study drug.

Conditions1

Interventions1

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