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

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 Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Peginterferon α-2b plus an anti-PD-1; Drug: Peginterferon α-2b plus an anti-PD-1; Drug: Peginterferon α-2b plus an anti-PD-1

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feng Ye; Phone Number: +86-592-2137569; Email: yefengdoctor@sina.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China
      • The First Affiliated Hospital of Xiamen University
      • Contact: Feng Ye; Phone Number: +86-592-2137569; Email: yefengdoctor@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Understand and voluntarily sign the informed consent form (ICF). 2. Aged ≥18 years and ≤75 years. 3. Histologically, cytologically, or radiologically confirmed diagnosis of advanced or metastatic malignant solid tumor, with prior standard treatment failure, no standard treatment available, or intolerance to standard treatment.

  4. At least one measurable lesion per RECIST v1.1, confirmed by computed tomography (CT) and/or magnetic resonance imaging (MRI).

  5. Absolute Monocyte Count (AMC) <0.25×10^9/L (tested by local lab; one retest is allowed if screening AMC is between 0.25-0.35×10^9/L).

  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Life expectancy ≥3 months. 8. Adequate organ function within 1 week prior to first study drug administration (no transfusion or blood products, no hematopoietic growth factors for correction within 14 days prior to screening):

• Hematology: White blood cell count ≥3.0×10^9/L, Absolute Neutrophil Count (ANC) ≥1.5×10^9/L, Platelet count ≥50×10^9/L, Hemoglobin ≥90 g/L.
• Hepatic: Serum total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert's syndrome); AST and ALT ≤2.5×ULN (≤5×ULN for liver metastases); Alkaline phosphatase (ALP) ≤2×ULN (≤5×ULN for bone or liver metastases).
• Renal: Urea/BUN and serum creatinine ≤1.5×ULN OR creatinine clearance ≥50 mL/min (Cockcroft-Gault formula).

• Coagulation: International Normalized Ratio (INR) and prothrombin time (PT) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5×ULN.

  9. For women of childbearing potential: negative pregnancy test within 1 week prior to first dose. All subjects of childbearing potential and their partners must agree to use effective contraception during the study and for 6 months after the last dose.

  10. For subjects who are HBsAg positive and/or HBcAb positive: HBV DNA <2000 IU/mL, must continue or initiate anti-HBV therapy (e.g., entecavir, tenofovir disoproxil fumarate). For subjects who are HCV-Ab positive: HCV RNA below the lower limit of detection.

Exclusion Criteria:

• 1. History of another active malignancy within the past 5 years (except for cured malignancies like thyroid cancer, basal cell carcinoma, cervical carcinoma in situ).

  2. Clinically significant moderate to severe ascites. 3. History of gastrointestinal hemorrhage or definitive gastrointestinal bleeding tendency within 6 months prior to study treatment.

  4. Abdominal fistula, gastrointestinal perforation, or intraperitoneal abscess within 6 months prior to study treatment.

  5. Known hereditary or acquired bleeding or thrombotic tendency. 6. History of thrombosis or thromboembolic events within 6 months prior to study treatment.

  7. Poorly controlled cardiac clinical symptoms or disease. 8. Hypertension inadequately controlled by antihypertensive medication. 9. Factors affecting oral administration. 10. Prior or current central nervous system metastases. 11. HIV positive, tuberculosis positive, or co-infection with HBV and HCV. 12. Prior or planned organ or allogeneic bone marrow transplantation. 13. Interstitial lung disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity.

  14. Known or suspected active autoimmune disease. 15. Requiring systemic treatment with corticosteroids or other immunosuppressants within 14 days prior to the first study treatment.

  16. Use of strong CYP3A4 inducers or inhibitors within 2 weeks prior to signing ICF.

  17. Known history of severe allergy to interferon, any monoclonal antibody, or cytidine nucleoside analogue antitumor drugs.

  18. Severe infection within 4 weeks prior to study treatment. 19. Palliative radiotherapy for non-target lesions is allowed but must be completed at least 2 weeks before study treatment.

  20. Treatment with another investigational drug within 28 days prior to study treatment.

  21. Major surgery or medical device treatment within 28 days prior to study treatment.

  22. Any other condition deemed by the investigator to be inappropriate for participation in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peg-IFNα2b 90μg Cohort	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).
Experimental: Peg-IFNα2b 135μg Cohort	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).
Experimental: Peg-IFNα2b 180μg Cohort	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University
• Investigators: Principal Investigator: Feng Ye, The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: XMYY-2025KY199-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No