Advanced Solid TumorsNCT07438093
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
A study testing Peginterferon α-2b plus an anti-PD-1 in people with Advanced Solid Tumors, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Peginterferon α-2b plus an anti-PD-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Feng Ye, +86-592-2137569, yefengdoctor@sina.com
About this study
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
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
- Being tested
- Peginterferon α-2b plus an anti-PD-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon α-2b plus an anti-PD-1Drug
Anti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (90 μg, weekly, SC).
Peginterferon α-2b plus an anti-PD-1Drug
Anti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (135 μg, weekly, SC).
Peginterferon α-2b plus an anti-PD-1Drug
Anti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (180 μg, weekly, SC).
| Study group | Role | What they receive |
|---|---|---|
| Peg-IFNα2b 90μg Cohort | Experimental | Not described Receives: Drug: Peginterferon α-2b plus an anti-PD-1 |
| Peg-IFNα2b 135μg Cohort | Experimental | Not described Receives: Drug: Peginterferon α-2b plus an anti-PD-1 |
| Peg-IFNα2b 180μg Cohort | Experimental | Not described Receives: Drug: Peginterferon α-2b plus an anti-PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Ye, Principal investigator, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438093
- Sponsor's protocol ID
- XMYY-2025KY199-01
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07438093
- Acronym / sponsor ID
- XMYY-2025KY199-01
- Conditions
- Advanced Solid Tumors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peg-IFNα2b 90μg Cohort | Experimental | Drug: Peginterferon α-2b plus an anti-PD-1 |
| Peg-IFNα2b 135μg Cohort | Experimental | Drug: Peginterferon α-2b plus an anti-PD-1 |
| Peg-IFNα2b 180μg Cohort | Experimental | Drug: Peginterferon α-2b plus an anti-PD-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon α-2b plus an anti-PD-1Anti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (90 μg, weekly, SC). | Drug | Peg-IFNα2b 90μg Cohort |
| Peginterferon α-2b plus an anti-PD-1Anti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (135 μg, weekly, SC). | Drug | Peg-IFNα2b 135μg Cohort |
| Peginterferon α-2b plus an anti-PD-1Anti-PD-1 antibody (200 mg, Q3W, IV) plus peginterferon alfa-2b (180 μg, weekly, SC). | Drug | Peg-IFNα2b 180μg Cohort |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: During the first treatment cycle (21 days) of the dose-escalation phase.
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.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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).
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.
Incidence of Clinically Significant Laboratory Abnormalities
Time frame: 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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng Ye principal investigator
The First Affiliated Hospital of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peginterferon α-2b plus an anti-PD-1 in people with Advanced Solid Tumors, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Ye (+86-592-2137569, yefengdoctor@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: During the first treatment cycle (21 days) of the dose-escalation phase.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.