CancerPhase 1NCT07538648
A Phase II Clinical Study Evaluating the Effectiveness of Injectable NC527-X in Intraoperative Imaging for Patients With Solid Tumors
A Phase 1 study testing Experimental:Preoperative injection of NC527-X in people with Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Evaluate the initial dose-effect and time-effect relationship of the injection product NC527-X Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Experimental:Preoperative injection of NC527-X
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2025to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Voluntarily sign a written informed consent form;
- 2. Male and female individuals aged 18 years or above;
- 3. Patients with solid tumors that have been diagnosed by imaging tests or confirmed by pathology and who are scheduled for surgical removal;
- 4. The ECOG score ranges from 0 to 1;
- 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. 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.
Who cannot join
- 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. 28 days prior to the first administration, the subject had received a similar drug (such as indocyanine green for injection);
- 3. Within one month prior to the first administration, participants were enrolled in another clinical study (including observational or non-interventional clinical studies);
- 4. Within 28 days prior to the first administration, had received a live attenuated vaccine;
- 5. Within one month prior to the first administration, had undergone major surgical procedures (as defined by the investigators);
- 6. The subjects had previously undergone allogeneic stem cell or solid organ transplantation;
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- 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. 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. 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. 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. 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. 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. 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. 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Yizhou Wei, 18858556819, weiyz_1019@163.com
About this study
Evaluate the initial dose-effect and time-effect relationship of the injection product NC527-X
- Conditions
- Cancer
- Being tested
- Experimental:Preoperative injection of NC527-X
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental:Preoperative injection of NC527-XDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Experimental:Preoperative injection of NC527-X |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the 1st to the 3rd day after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start24 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538648
- Sponsor's protocol ID
- IRB-2025-1849 (IIT)
- Status last verified
- Dec 2025
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study Evaluating the Effectiveness of Injectable NC527-X in Intraoperative Imaging for Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07538648
- Acronym / sponsor ID
- IRB-2025-1849 (IIT)
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the initial dose-effect and time-effect relationship of the injection product NC527-X
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental:Preoperative injection of NC527-X | Experimental | Drug: Experimental:Preoperative injection of NC527-XThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Voluntarily sign a written informed consent form;
- 2. Male and female individuals aged 18 years or above;
- 3. Patients with solid tumors that have been diagnosed by imaging tests or confirmed by pathology and who are scheduled for surgical removal;
- 4. The ECOG score ranges from 0 to 1;
- 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.
Key exclusion criteria (14 listed)
- 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. 28 days prior to the first administration, the subject had received a similar drug (such as indocyanine green for injection);
- 3. Within one month prior to the first administration, participants were enrolled in another clinical study (including observational or non-interventional clinical studies);
- 4. Within 28 days prior to the first administration, had received a live attenuated vaccine;
- 5. Within one month prior to the first administration, had undergone major surgical procedures (as defined by the investigators);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental:Preoperative injection of NC527-XThis 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 |
Primary outcome
Signal-to-Background Ratio (SBR)
Time frame: From the 1st to the 3rd day after administration
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Experimental:Preoperative injection of NC527-X in people with Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangdong Cheng Cheng (0086-571-881280, Chengxd516@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal-to-Background Ratio (SBR) (time frame: From the 1st to the 3rd day after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.