Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:58 AM
Study NCT ID:
NCT07438093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: