N-3C01 Monotherapy and Combination With PD-(L)1 Inhibitors in Advanced Solid Tumors

NCT07639450 | Not Yet Recruiting Phase 1

• 1 other identifier: YF-N01-002
• Study Type: interventional
• Target: 114
• Locations: 2 countries
• Sites: 6

Brief 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. Phase I involves dose escalation for both monotherapy and combination therapy, while Phase II includes cohort expansion for the combination therapy.

Conditions

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (9)

• 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.

  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 (%).

  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'.

  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'.

  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'.

  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'.

  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'.

  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).

  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'.

  From screening to safety follow-up , up to approximately 24 months

Secondary Outcomes (12)

• Maximum concentration (Cmax)

  From start of treatment to end of treatment, up to approximately 24 months

• Area under the curve (AUC)

  From start of treatment to end of treatment, up to approximately 24 months.

• Tmax

  From start of treatment to end of treatment, up to approximately 24 months

• Clearance (CL)

  From start of treatment to end of treatment, up to approximately 24 months

• half-life (t1/2)

  From start of treatment to end of treatment, up to approximately 24 months.

Study Arms (3)

N-3C01 monotherapy(Q2W)

EXPERIMENTAL

Eligible participants will be administered a subcutaneous injection of N-3C01 every 2 weeks.

Drug: N-3C01(Q2W)

N-3C01 monotherapy (Q3W)

EXPERIMENTAL

Eligible participants will be administered a N-3C01 subcutaneous injection every 3 weeks.

Drug: N-3C01(Q3W)

N-3C01 plus pembrolizumab

EXPERIMENTAL

Eligible participants with selected tumors will receive N-3C01(subcutaneous injection) and pembrolizumab (intravenous injection).

Drug: N-3C01; Drug: Pembrolizumab

Interventions

N-3C01(Q2W) DRUG

subcutaneous injection once every 2 weeks

N-3C01 monotherapy(Q2W)

N-3C01(Q3W) DRUG

subcutaneous injection once every 3 weeks

N-3C01 monotherapy (Q3W)

N-3C01 DRUG

subcutaneous injection once every 2 or 3 weeks.

N-3C01 plus pembrolizumab

Pembrolizumab DRUG

intravenous injection once every 3 weeks

N-3C01 plus pembrolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Hefei Xinzhu Biological Technology Co., Ltd.: lead

Study Sites (6)

GenesisCare Research

Saint Leonards, New South Wales, 2065, Australia

Location

San Clinical Trials Unit

Wahroonga, New South Wales, 2076, Australia

Location

Corner Edith & Platt Streets, , NSW 2298 Australia

Waratah, New South Wales, 2298, Australia

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Henan Cancer Hospital

Zhengzhou, Zhengzhou, 450000, China

Location

MeSH Terms

Interventions

pembrolizumab

Central Study Contacts

Karen Zhou

CONTACT

+8613521345200; Karen.zhou@novotech-cro.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: phase 1 is sequential; phase 2 is parallel.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 10, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

AU (3); CN (3)