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NOT YET RECRUITING
NCT07438093
NA

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

Sponsor: The First Affiliated Hospital of Xiamen University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-04

Completion Date

2027-12

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

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).

Locations (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China