NCT07438093

Safety, Tolerability, and Preliminary Efficacy of Peginterferon α-2b in Combination With an Anti-PD-1 Antibody in Patients With Advanced or Metastatic Malignant Solid Tumors

An Open-Label, Dose-Escalation Clinical Study of Peginterferon Alfa-2b in Combination With an Anti-PD-1 Antibody to Evaluate the Safety, Tolerability, and Preliminary Efficacy in Patients With Advanced or Metastatic Malignant Solid Tumors

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Peginterferon α-2b plus an anti-PD-1	Anti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (90 μg, weekly, SC).
DRUG	Peginterferon α-2b plus an anti-PD-1	Anti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (135 μg, weekly, SC).
DRUG	Peginterferon α-2b plus an anti-PD-1	Anti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (180 μg, weekly, SC).

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-12-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: China