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

NCT07538648 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB-2025-1849 (IIT)
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Signal-to-Background Ratio (SBR)

  Signal-to-Background Ratio (SBR): The ratio of the average signal intensity of the target area (tumor) to the average signal intensity of the background tissue.

  From the 1st to the 3rd day after administration

Study Arms (1)

Experimental:Preoperative injection of NC527-X

EXPERIMENTAL

This study will set up four single-arm dose groups (A, B, C, D), and it will be conducted in patients with solid tumors who have been diagnosed and are scheduled for surgical resection (evaluated by the researchers to have no surgical contraindications). The study will initially assign patients to groups A, B, C, and D respectively, with each group planning to include at least 3 cases, and a total of no more than 100 cases will be enrolled. The dosages will be 0.005 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.04 mg/kg, and the imaging time window after administration will be 24 to 72 hours.

Drug: Experimental:Preoperative injection of NC527-X

Interventions

Experimental:Preoperative injection of NC527-X DRUG

This study will set up four single-arm dose groups (A, B, C, D), and it will be conducted in patients with solid tumors who have been diagnosed and are scheduled for surgical resection (evaluated by the researchers to have no surgical contraindications). The study will initially assign patients to groups A, B, C, and D respectively, with each group planning to include at least 3 cases, and a total of no more than 100 cases will be enrolled. The dosages will be 0.005 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.04 mg/kg, and the imaging time window after administration will be 24 to 72 hours.

Experimental:Preoperative injection of NC527-X

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily sign a written informed consent form;
• \. Male and female individuals aged 18 years or above;
• \. Patients with solid tumors that have been diagnosed by imaging tests or confirmed by pathology and who are scheduled for surgical removal;
• \. The ECOG score ranges from 0 to 1;
• \. During the trial period, the subjects used effective contraceptive methods and continued to use contraception for another 3 months after the medication was completed.
• \. 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.

You may not qualify if:

• \. 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.
• \. 28 days prior to the first administration, the subject had received a similar drug (such as indocyanine green for injection);
• \. Within one month prior to the first administration, participants were enrolled in another clinical study (including observational or non-interventional clinical studies);
• \. Within 28 days prior to the first administration, had received a live attenuated vaccine;
• \. Within one month prior to the first administration, had undergone major surgical procedures (as defined by the investigators);
• \. The subjects had previously undergone allogeneic stem cell or solid organ transplantation;
• \. 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);
• \. 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);
• \. 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);
• \. 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.
• \. 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;
• \. 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.
• \. 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Xiangdong Cheng Cheng

CONTACT

0086-571-881280; Chengxd516@126.com

Can Hu Hu

CONTACT

13968032995; chengxd@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Secretary of the party committee

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: December 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2025-12

Locations

CN (1)