Advanced Malignant Solid TumorsPhase 1/2Solid TumorsNCT07639450
N-3C01 Monotherapy and Combination With PD-(L)1 Inhibitors in Advanced Solid Tumors
A Phase 1/2 study testing N-3C01(Q2W), N-3C01(Q3W) and N-3C01 in people with Advanced Malignant Solid Tumors, run by Hefei Xinzhu Biological Technology Co., Ltd. at 6 sites in 2 countries.
Trial summary
This Phase I/II study evaluates the safety, tolerability, and efficacy of N-3C01 administered subcutaneously, both as monotherapy and in combination with a PD-(L)1 monoclonal antibody, in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- N-3C01(Q2W), N-3C01(Q3W) and N-3C01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 15 Jun 2026to 30 Sep 2028
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to voluntarily participate in the study and provide written informed consent.
- Age 18 to 75 years (inclusive) at the time of signing the informed consent form, regardless of gender.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (refer to Appendix 1).
- Estimated life expectancy of ≥3 months.
- Disease criteria:
- Phase I: Patients with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors who have progressed following standard systemic therapy, have no available standard treatment options, are intolerant to standard therapies, or are deemed unsuitable for standard treatment by the Investigator.
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- Phase II:
- Cohort 1: Advanced non-small cell lung cancer (NSCLC) with progression after immune checkpoint inhibitor therapy (as monotherapy or in combination with chemotherapy).
- Cohort 2: Advanced melanoma with progression following chemotherapy and/or immune checkpoint inhibitor therapy.
- Other cohorts: Tumor types such as colorectal cancer, renal cell carcinoma, head and neck squamous cell carcinoma, etc., that have progressed after chemotherapy and/or immune checkpoint inhibitor therapy and are considered potentially responsive by the Investigator.
- Presence of at least one measurable lesion per RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 (except for participants enrolled in the monotherapy dose-escalation phase).
- Adequate organ function.
- Use of effective contraception during the treatment period and for at least 3 months after the last dose.
Who cannot join
- Presence of unstable central nervous system (CNS) metastases or concurrent primary intracranial tumors requiring treatment. Participants may be eligible if CNS disease is asymptomatic, radiologically stable for at least 4 weeks prior to the first dose, and does not require corticosteroids or anticonvulsant therapy.
- History of two or more primary malignancies, except for adequately treated and controlled malignancies such as cervical carcinoma in situ, breast carcinoma in situ, basal cell or squamous cell carcinoma of the skin, and papillary thyroid carcinoma, with no evidence of recurrence within the past 2 years.
- Uncontrolled tumor-related pain. Participants requiring analgesics must be on a stable pain management regimen at study entry.
- Uncontrolled pleural effusion, pericardial effusion, or ascites. Participants may be eligible if drainage is not required or if fluid accumulation remains stable for at least 3 days following drainage.
- Presence of significant pulmonary conditions, including idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or active pneumonitis at screening. Participants with prior radiation-induced pneumonitis (fibrotic changes confined to the radiation field) may be included.
- History of autoimmune disease, except for conditions that are well-controlled, including type 1 diabetes mellitus, hypothyroidism managed with hormone replacement, and dermatologic conditions not requiring systemic therapy (e.g., eczema, psoriasis, vitiligo, alopecia), as well as well-controlled celiac disease.
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- Receipt of systemic corticosteroids within 1 week prior to the first dose or other systemic immunosuppressive therapies within 2 weeks (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide), except for physiologic replacement doses of prednisone ≤10 mg/day (or equivalent).
- History of clinically significant cardiovascular disease, including but not limited to:
- Congestive heart failure (New York Heart Association [NYHA] class >2) Unstable angina Myocardial infarction within 3 months prior to the first study dose Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention
- History of clinically significant bleeding within 3 months prior to the first study dose. Participants with significant hemoptysis (i.e., coughing bright red blood of ≥2.5 mL per episode) within 1 month prior to the first dose are not eligible.
- History of arterial or venous thrombotic events within 6 months prior to the first study dose, including but not limited to cerebrovascular accident, deep vein thrombosis, or pulmonary embolism.
- Evidence of active tuberculosis (TB), as indicated by medical history or imaging (e.g., CT scan) within 1 year prior to enrollment, or a history of untreated active tuberculosis (TB) more than 1 year prior to screening.
- Severe infection within 4 weeks prior to the first study dose (e.g., bacteremia requiring hospitalization, severe pneumonia), or active infection requiring systemic antimicrobial therapy of CTCAE(Common Terminology Criteria for Adverse Events ) v6.0 Grade ≥2 within 2 weeks prior to dosing.
- Known history of immunodeficiency.
- Active viral or infectious diseases requiring treatment, including:
- Hepatitis B (HBsAg or HBeAg positive with Hepatitis C Virus (HBV) deoxyribonucleic acid (DNA) greater than or equal to 500 International Units per milliliter)
- Hepatitis C (positive Hepatitis C Virus (HCV) antibody with detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA))
- human immunodeficiency virus (HIV) infection
- Syphilis (positive serology with confirmatory Rapid Plasma Reagin (RPR)/TRUST test)
- Toxicities from prior anti-cancer therapy that have not resolved to baseline or ≤Grade 1 (per Common Terminology Criteria for Adverse Events (CTCAE) v6.0), except for adverse events that are not clinically significant (e.g., alopecia), as determined by the Investigator.
- Receipt of any anti-tumor therapy-including surgery, chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy, traditional Chinese medicine, or investigational agents-within 4 weeks prior to the first study dose or within 5 half-lives of the respective drug (whichever is longer). Palliative radiotherapy for bone metastases within 2 weeks prior to the first dose is also not permitted.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Australia3 sites, 3 recruiting
- Not yet recruiting
GenesisCare Research
Saint Leonards, New South Wales, 2065
Prof Nick Pavlakis
Prof Nick Pavlakis
- Not yet recruiting
San Clinical Trials Unit
Wahroonga, New South Wales, 2076
Dr. Csilla Hasovits
Dr. Csilla Hasovits
- Not yet recruiting
Corner Edith & Platt Streets, , NSW 2298 Australia
Waratah, New South Wales, 2298
Dr. Faisal Hayat
Dr. Faisal Hayat
China3 sites, 3 recruiting
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Jia Li
Jia Li
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200000
Cai Cun Zhou
Cai Cun Zhou
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Zhengzhou, 450000
Yanqiu Zhao
Yanqiu Zhao
About this study
Official title: A Phase I/II Clinical Study Evaluating the Safety, Tolerability, and Efficacy of N-3C01 as Monotherapy and in Combination With PD-(L)1 Monoclonal Antibody in Patients With Advanced Malignant Solid Tumors
This Phase I/II study evaluates the safety, tolerability, and efficacy of N-3C01 administered subcutaneously, both as monotherapy and in combination with a PD-(L)1 monoclonal antibody, in patients with advanced solid tumors. Phase I involves dose escalation for both monotherapy and combination therapy, while Phase II includes cohort expansion for the combination therapy.
Read the detailed description
This is a Phase I/II clinical study designed to evaluate the safety, tolerability, and efficacy of N-3C01 administered subcutaneously, both as monotherapy and in combination with a PD-(L)1 monoclonal antibody, in patients with advanced solid tumors. Phase I consists of dose escalation of N-3C01 as monotherapy and in combination with PD-(L)1 antibody, while Phase II involves cohort expansion of the combination therapy.
The Phase I study employs an escalation design. Participants will receive N-3C01 either as monotherapy or in combination with a fixed dose of PD-(L)1 monoclonal antibody. The study will assess safety, tolerability, and pharmacokinetics across different dose levels and dosing schedules to determine the maximum tolerated dose and the recommended Phase II dose (RP2D).
A Safety Review Committee (SRC), comprising the Investigator, Sponsor representative, and Medical Monitor, will oversee safety evaluations. The SRC will review dose-limiting toxicity data and provide recommendations on dose escalation, de-escalation, expansion, or study discontinuation and RP2D. In Phase II, eligible participants will receive N-3C01 at the RP2D in combination with a fixed dose of PD-(L)1 monoclonal antibody.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- N-3C01(Q2W), N-3C01(Q3W), N-3C01, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-3C01(Q2W)Drug
subcutaneous injection once every 2 weeks
N-3C01(Q3W)Drug
subcutaneous injection once every 3 weeks
N-3C01Drug
subcutaneous injection once every 2 or 3 weeks.
PembrolizumabDrug
intravenous injection once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| N-3C01 monotherapy(Q2W) | Experimental | Eligible participants will be administered a subcutaneous injection of N-3C01 every 2 weeks. Receives: Drug: N-3C01(Q2W) |
| N-3C01 monotherapy (Q3W) | Experimental | Eligible participants will be administered a N-3C01 subcutaneous injection every 3 weeks. Receives: Drug: N-3C01(Q3W) |
| N-3C01 plus pembrolizumab | Experimental | Eligible participants with selected tumors will receive N-3C01(subcutaneous injection) and pembrolizumab (intravenous injection). Receives: Drug: N-3C01; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicity (DLT)
All DLTs will be coded using the MedDRA® version 29.0 or higher by System Organ Class and Preferred Term, and graded according to CTCAE 6.0. The number and incidence of DLTs will be calculated and summarized by treatment group.
Measured: 28 days from the first study dose
Number of participants with adverse enents (AE), serious adverse events (SAEs), treatment-emergent AEs (TEAEs)
All AEs will be coded using the MedDRA® version 29.0 or higher and graded according to CTCAE 6.0. emphasis will be placed on TEAE. Summary tables will include the number of participants (n), frequency, and percentage (%).
Measured: From screening to safety follow-up , up to approximately 24 months
Number of participants with abnormality in vital signs
Vital signs measurements will present summary statistics for the results at the baseline and each scheduled post-baseline visit for each of the parameters. In addition, summaries will be presented for the change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). Clinical significant changes shift from baseline will also be presented using the classification 'Normal', 'Abnormal, Not clinically significant', 'Abnormal, clinically significant'.
Measured: From screening to safety follow-up , up to approximately 24 months
Number of participants with abnormality in ECG parameters
ECG measurements will present summary statistics for the results at the baseline and each scheduled post-baseline visit for each of the parameters. In addition, summaries will be presented for the change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). Clinical significant changes shift from baseline will also be presented using the classification 'Normal', 'Abnormal, Not clinically significant', 'Abnormal, clinically significant'.
Measured: From screening to safety follow-up , up to approximately 24 months
Number of participants with abnormality in hematology assessments
For each parameter, summaries will be presented for the baseline and each scheduled post-baseline visit. In addition, summaries will be presented for the change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). Clinical significant changes shift from baseline will also be presented using the classification 'Normal', 'Abnormal, Not clinically significant', 'Abnormal, clinically significant'.
Measured: From screening to safety follow-up , up to approximately 24 months
Number of participants with abnormality in blood chemistry parameters
For each parameter, summaries will be presented for the baseline and each scheduled post-baseline visit. In addition, summaries will be presented for the change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). Clinical significant changes shift from baseline will also be presented using the classification 'Normal', 'Abnormal, Not clinically significant', 'Abnormal, clinically significant'.
Measured: From screening to safety follow-up , up to approximately 24 months
Number of participants with abnormality in coagulation parameters
Each measurement will present summary statistics for the results at the baseline and each scheduled post-baseline visit for each of the parameters. In addition, summaries will be presented for the change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). Clinical significant changes shift from baseline will also be presented using the classification 'Normal', 'Abnormal, Not clinically significant', 'Abnormal, clinically significant'.
Measured: From screening to safety follow-up , up to approximately 24 months
Number of participants with abnormality in routine urinalysis parameters
The urinalysis table will present clinically significant for the reported results at baseline and each post-baseline visit for all parameters (categorical descriptive analysis).
Measured: From screening to safety follow-up , up to approximately 24 months
Number of participants with abnormality in thyroid function parameters
For each parameter, summaries will be presented for the baseline and each scheduled post-baseline visit. In addition, summaries will be presented for the change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). Clinical significant changes shift from baseline will also be presented using the classification 'Normal', 'Abnormal, Not clinically significant', 'Abnormal, clinically significant'.
Measured: From screening to safety follow-up , up to approximately 24 months
Secondary outcomes (12)
Maximum concentration (Cmax)
Maximum plasma drug concentration obtained directly from the plasma concentration time profiles.
Measured: From start of treatment to end of treatment, up to approximately 24 months
Area under the curve (AUC)
AUC will be determined when appropriate. Analyses will be performed on the plasma PKPS using the actual sampling times.
Measured: From start of treatment to end of treatment, up to approximately 24 months.
Tmax
Time to maximum observed plasma drug concentration.
Measured: From start of treatment to end of treatment, up to approximately 24 months
Clearance (CL)
Apparent total plasma clearance will be determined when appropriate.
Measured: From start of treatment to end of treatment, up to approximately 24 months
half-life (t1/2)
t1/2 will be determined when appropriate.
Measured: From start of treatment to end of treatment, up to approximately 24 months.
Volume of distribution (V)
Volume of distribution will be determined when appropriate.
Measured: From start of treatment to end of treatment, up to approximately 24 months
The incidence of ADA and NAb of N-3C01
The number and percentage of positive participants with anti-drug antibodies will be summarized. All immunogenicity data will also be presented in a by-participant data listing.
Measured: From start of treatment to end of treatment, up to approximately 24 months
Objective response rate (ORR)
ORR is defined as the percentage of participants with a best overall response of CR or PR according to RECIST v1.1.
Measured: From start of treatment to end of treatment, up to approximately 24 months
Disease control rate (DCR)
DCR is defined as the percentage of participants with a best overall response of CR, PR or SD accoding to RECIST v1.1.
Measured: From start of treatment to end of treatment, up to approximately 24 months
Duration of response (DoR)
For participants who achieve a confirmed response (CR or PR), Duration of Response is defined as the time from the first date of response until disease progression or death, whichever occurs first.
Measured: From start of treatment to end of treatment, up to approximately 24 months.
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of N-3C01 to the first occurrence of disease progression (radiographic) or death, whichever occurs first. In progression-free patients, PFS will be censored at the time of the last evaluable tumor assessment.
Measured: From start of treatment to safety follow-up, up to approximately 24 months
Overall Survival (OS)
OS is defined as the time from the first dose of N-3C01 to participant death. Patients alive or lost to follow-up will be censored at the last date known to be alive.
Measured: From start of treatment to end of treatment, up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start15 Jun 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorsStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- phase 1 is sequential; phase 2 is parallel.
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hefei Xinzhu Biological Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639450
- Sponsor's protocol ID
- YF-N01-002
- Acronym
- Solid Tumors
- Status last verified
- Sep 2026
- First submitted
- 18 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study Evaluating the Safety, Tolerability, and Efficacy of N-3C01 as Monotherapy and in Combination With PD-(L)1 Monoclonal Antibody in Patients With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07639450
- Acronym / sponsor ID
- Solid Tumors / YF-N01-002
- Conditions
- Advanced Malignant Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Hefei Xinzhu Biological Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 10 Jun 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.
This Phase I/II study evaluates the safety, tolerability, and efficacy of N-3C01 administered subcutaneously, both as monotherapy and in combination with a PD-(L)1 monoclonal antibody, in patients with advanced solid tumors. Phase I involves dose escalation for both monotherapy and combination therapy, while Phase II includes cohort expansion for the combination therapy.
Detailed description
This is a Phase I/II clinical study designed to evaluate the safety, tolerability, and efficacy of N-3C01 administered subcutaneously, both as monotherapy and in combination with a PD-(L)1 monoclonal antibody, in patients with advanced solid tumors. Phase I consists of dose escalation of N-3C01 as monotherapy and in combination with PD-(L)1 antibody, while Phase II involves cohort expansion of the combination therapy.
The Phase I study employs an escalation design. Participants will receive N-3C01 either as monotherapy or in combination with a fixed dose of PD-(L)1 monoclonal antibody. The study will assess safety, tolerability, and pharmacokinetics across different dose levels and dosing schedules to determine the maximum tolerated dose and the recommended Phase II dose (RP2D).
A Safety Review Committee (SRC), comprising the Investigator, Sponsor representative, and Medical Monitor, will oversee safety evaluations. The SRC will review dose-limiting toxicity data and provide recommendations on dose escalation, de-escalation, expansion, or study discontinuation and RP2D. In Phase II, eligible participants will receive N-3C01 at the RP2D in combination with a fixed dose of PD-(L)1 monoclonal antibody.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- phase 1 is sequential; phase 2 is parallel.
| Arm | Type | Receives |
|---|---|---|
| N-3C01 monotherapy(Q2W) | Experimental | Drug: N-3C01(Q2W)Eligible participants will be administered a subcutaneous injection of N-3C01 every 2 weeks. |
| N-3C01 monotherapy (Q3W) | Experimental | Drug: N-3C01(Q3W)Eligible participants will be administered a N-3C01 subcutaneous injection every 3 weeks. |
| N-3C01 plus pembrolizumab | Experimental | Drug: N-3C01, Drug: PembrolizumabEligible participants with selected tumors will receive N-3C01(subcutaneous injection) and pembrolizumab (intravenous injection). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willingness to voluntarily participate in the study and provide written informed consent.
- Age 18 to 75 years (inclusive) at the time of signing the informed consent form, regardless of gender.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (refer to Appendix 1).
- Estimated life expectancy of ≥3 months.
- Disease criteria:
Key exclusion criteria (21 listed)
- Presence of unstable central nervous system (CNS) metastases or concurrent primary intracranial tumors requiring treatment. Participants may be eligible if CNS disease is asymptomatic, radiologically stable for at least 4 weeks prior to the first dose, and does not require corticosteroids or anticonvulsant therapy.
- History of two or more primary malignancies, except for adequately treated and controlled malignancies such as cervical carcinoma in situ, breast carcinoma in situ, basal cell or squamous cell carcinoma of the skin, and papillary thyroid carcinoma, with no evidence of recurrence within the past 2 years.
- Uncontrolled tumor-related pain. Participants requiring analgesics must be on a stable pain management regimen at study entry.
- Uncontrolled pleural effusion, pericardial effusion, or ascites. Participants may be eligible if drainage is not required or if fluid accumulation remains stable for at least 3 days following drainage.
- Presence of significant pulmonary conditions, including idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or active pneumonitis at screening. Participants with prior radiation-induced pneumonitis (fibrotic changes confined to the radiation field) may be included.
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 |
|---|---|---|
| N-3C01(Q2W)subcutaneous injection once every 2 weeks | Drug | N-3C01 monotherapy(Q2W) |
| N-3C01(Q3W)subcutaneous injection once every 3 weeks | Drug | N-3C01 monotherapy (Q3W) |
| N-3C01subcutaneous injection once every 2 or 3 weeks. | Drug | N-3C01 plus pembrolizumab |
| Pembrolizumabintravenous injection once every 3 weeks | Drug | N-3C01 plus pembrolizumab |
Primary outcome
Number of participants with dose-limiting toxicity (DLT)
Time frame: 28 days from the first study dose
All DLTs will be coded using the MedDRA® version 29.0 or higher by System Organ Class and Preferred Term, and graded according to CTCAE 6.0. The number and incidence of DLTs will be calculated and summarized by treatment group.
Number of participants with adverse enents (AE), serious adverse events (SAEs), treatment-emergent AEs (TEAEs)
Time frame: From screening to safety follow-up , up to approximately 24 months
All AEs will be coded using the MedDRA® version 29.0 or higher and graded according to CTCAE 6.0. emphasis will be placed on TEAE. Summary tables will include the number of participants (n), frequency, and percentage (%).
Number of participants with abnormality in vital signs
Time frame: From screening to safety follow-up , up to approximately 24 months
Vital signs measurements will present summary statistics for the results at the baseline and each scheduled post-baseline visit for each of the parameters. In addition, summaries will be presented for the change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). Clinical significant changes shift from baseline will also be presented using the classification 'Normal', 'Abnormal, Not clinically significant', 'Abnormal, clinically significant'.
Number of participants with abnormality in ECG parameters
Time frame: From screening to safety follow-up , up to approximately 24 months
ECG measurements will present summary statistics for the results at the baseline and each scheduled post-baseline visit for each of the parameters. In addition, summaries will be presented for the change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). Clinical significant changes shift from baseline will also be presented using the classification 'Normal', 'Abnormal, Not clinically significant', 'Abnormal, clinically significant'.
Number of participants with abnormality in hematology assessments
Time frame: From screening to safety follow-up , up to approximately 24 months
For each parameter, summaries will be presented for the baseline and each scheduled post-baseline visit. In addition, summaries will be presented for the change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). Clinical significant changes shift from baseline will also be presented using the classification 'Normal', 'Abnormal, Not clinically significant', 'Abnormal, clinically significant'.
Number of participants with abnormality in blood chemistry parameters
Time frame: From screening to safety follow-up , up to approximately 24 months
For each parameter, summaries will be presented for the baseline and each scheduled post-baseline visit. In addition, summaries will be presented for the change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). Clinical significant changes shift from baseline will also be presented using the classification 'Normal', 'Abnormal, Not clinically significant', 'Abnormal, clinically significant'.
Number of participants with abnormality in coagulation parameters
Time frame: From screening to safety follow-up , up to approximately 24 months
Each measurement will present summary statistics for the results at the baseline and each scheduled post-baseline visit for each of the parameters. In addition, summaries will be presented for the change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). Clinical significant changes shift from baseline will also be presented using the classification 'Normal', 'Abnormal, Not clinically significant', 'Abnormal, clinically significant'.
Number of participants with abnormality in routine urinalysis parameters
Time frame: From screening to safety follow-up , up to approximately 24 months
The urinalysis table will present clinically significant for the reported results at baseline and each post-baseline visit for all parameters (categorical descriptive analysis).
Number of participants with abnormality in thyroid function parameters
Time frame: From screening to safety follow-up , up to approximately 24 months
For each parameter, summaries will be presented for the baseline and each scheduled post-baseline visit. In addition, summaries will be presented for the change from baseline values at each scheduled post-baseline visit (continuous descriptive analysis). Clinical significant changes shift from baseline will also be presented using the classification 'Normal', 'Abnormal, Not clinically significant', 'Abnormal, clinically significant'.
12 secondary outcomes
Maximum concentration (Cmax)
Time frame: From start of treatment to end of treatment, up to approximately 24 months
Area under the curve (AUC)
Time frame: From start of treatment to end of treatment, up to approximately 24 months.
Tmax
Time frame: From start of treatment to end of treatment, up to approximately 24 months
Clearance (CL)
Time frame: From start of treatment to end of treatment, up to approximately 24 months
half-life (t1/2)
Time frame: From start of treatment to end of treatment, up to approximately 24 months.
Volume of distribution (V)
Time frame: From start of treatment to end of treatment, up to approximately 24 months
The incidence of ADA and NAb of N-3C01
Time frame: From start of treatment to end of treatment, up to approximately 24 months
Objective response rate (ORR)
Time frame: From start of treatment to end of treatment, up to approximately 24 months
Disease control rate (DCR)
Time frame: From start of treatment to end of treatment, up to approximately 24 months
Duration of response (DoR)
Time frame: From start of treatment to end of treatment, up to approximately 24 months.
Progression-Free Survival (PFS)
Time frame: From start of treatment to safety follow-up, up to approximately 24 months
Overall Survival (OS)
Time frame: From start of treatment to end of treatment, up to approximately 24 months
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 17 Sep 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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing N-3C01(Q2W), N-3C01(Q3W) and N-3C01 in people with Advanced Malignant Solid Tumors, run by Hefei Xinzhu Biological Technology Co., Ltd. at 6 sites in 2 countries.
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 13 inclusion and 21 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Karen Zhou (+8613521345200, Karen.zhou@novotech-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose-limiting toxicity (DLT) (time frame: 28 days from the first study dose). The study lists 9 primary outcomes in all. 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 17 Sep 2026.