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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Anti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (90 μg, weekly, SC).
Anti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (135 μg, weekly, SC).
Anti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (180 μg, weekly, SC).
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
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.
Time frame: During the first treatment cycle (21 days) of the dose-escalation phase.
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.
Time frame: From first dose of study drug up to 28 days after the last dose, or until start of new anti-cancer therapy, whichever occurs first (approximately up to 24 months).
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.
Time frame: From first dose of study drug up to 28 days after the last dose, or until start of new anti-cancer therapy, whichever occurs first (approximately up to 24 months).
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