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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

NCT07438093 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-27

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    lead OTHER

Principal Investigators

  • Feng Ye · The First Affiliated Hospital of Xiamen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07438093 on ClinicalTrials.gov