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.
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.
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.
Sequential
N-3C01(Q2W)
Drugsubcutaneous injection once every 2 weeks
N-3C01(Q3W)
Drugsubcutaneous injection once every 3 weeks
N-3C01
Drugsubcutaneous injection once every 2 or 3 weeks.
Pembrolizumab
Drugintravenous injection once every 3 weeks
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.
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 (%).
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'.
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'.
Maximum concentration (Cmax)
Maximum plasma drug concentration obtained directly from the plasma concentration time profiles.
Area under the curve (AUC)
AUC will be determined when appropriate. Analyses will be performed on the plasma PKPS using the actual sampling times.
Tmax
Time to maximum observed plasma drug concentration.
Clearance (CL)
Apparent total plasma clearance will be determined when appropriate.
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