This study is an open-label, dose-escalation phase I clinical trial conducted in patients with advanced or metastatic solid tumors in China.This study is an open-label, dose-escalation phase I clinical trial conducted in patients with advanced or metastatic solid tumors in China. The aim is to evaluate the safety, tolerability and preliminary efficacy of pegylated interferon alpha-2b (Peg-IFNα2b) combined with PD-1 monoclonal antibody.
The aim is to evaluate the safety, tolerability and preliminary efficacy of pegylated interferon alpha-2b (Peg-IFNα2b) combined with PD-1 monoclonal antibody.
The study adopts the classic "3+3" dose escalation design and plans to enroll approximately 60 patients.The study adopts the classic "3+3" dose escalation design and plans to enroll approximately 60 patients. The first part is the dose escalation stage, aiming to determine the maximum tolerated dose (MTD) or the recommended phase II dose (RP2D) for the combined treatment. The first part is the dose escalation stage, aiming to determine the maximum tolerated dose (MTD) or the recommended phase II dose (RP2D) for the combined treatment. The second part is the expansion stage, where the efficacy signals will be further observed at the selected dose. The second part is the expansion stage, where the efficacy signals will be further observed at the selected dose. The primary endpoints are treatment-related adverse events and dose-limiting toxicities (DLT), while the secondary endpoints include objective response rate (ORR), progression-free survival (PFS), etc. The primary endpoints are treatment-related adverse events and dose-limiting toxicities (DLT), while the secondary endpoints include objective response rate (ORR), progression-free survival (PFS), etc. The study period is planned to be 12 months. The study period is planned to be 12 months.
1. Understand and voluntarily sign the informed consent form (ICF). 2. Aged ≥18 years and ≤75 years. 3. Histologically, cytologically, or radiologically confirmed diagnosis of advanced or metastatic malignant solid tumor, with prior standard treatment failure, no standard treatment available, or intolerance to standard treatment.
Hematology: White blood cell count ≥3.0×10^9/L, Absolute Neutrophil Count (ANC) ≥1.5×10^9/L, Platelet count ≥50×10^9/L, Hemoglobin ≥90 g/L.
Hepatic: Serum total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert's syndrome); AST and ALT ≤2.5×ULN (≤5×ULN for liver metastases); Alkaline phosphatase (ALP) ≤2×ULN (≤5×ULN for bone or liver metastases).
Renal: Urea/BUN and serum creatinine ≤1.5×ULN OR creatinine clearance ≥50 mL/min (Cockcroft-Gault formula).
1. History of another active malignancy within the past 5 years (except for cured malignancies like thyroid cancer, basal cell carcinoma, cervical carcinoma in situ).
Sequential
Peginterferon α-2b plus an anti-PD-1
DrugAnti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (90 μg, weekly, SC).
Peginterferon α-2b plus an anti-PD-1
DrugAnti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (135 μg, weekly, SC).
Peginterferon α-2b plus an anti-PD-1
DrugAnti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (180 μg, weekly, SC).
Incidence of Dose-Limiting Toxicities (DLTs)
Number of participants experiencing a Dose-Limiting Toxicity (DLT) during the first treatment cycle (21 days) of the dose-escalation phase. DLTs are defined per protocol and assessed using CTCAE v5.0, including specific severe hematologic toxicities (e.g., prolonged Grade 4 neutropenia, febrile neutropenia) and non-hematologic toxicities (e.g., severe liver enzyme elevations, other Grade 3/4 toxicities unresponsive to supportive care) that are considered related to the study drugs.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and percentage of participants with any treatment-emergent adverse event (TEAE), treatment-related adverse event (TRAE), and serious adverse event (SAE). Severity will be graded according to NCI CTCAE version 5.0, and relationship to study drugs will be assessed by the investigator.
Incidence of Clinically Significant Laboratory Abnormalities
Number of participants with clinically significant abnormalities in laboratory parameters (including hematology, clinical chemistry, and coagulation) relative to baseline, as assessed by the investigator. Significance is defined as an abnormality that leads to a change in study drug dose, requires medical intervention, or is considered clinically significant by the investigator.
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