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Experimental combo aims to boost immune attack on tough cancers

NCT ID NCT07438093

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a combination of two drugs—peginterferon alfa-2b and an anti-PD-1 antibody—in about 60 people with advanced or metastatic solid tumors who have no standard treatment options left. The main goal is to find a safe dose and check for side effects. Researchers will also look for early signs that the combo might shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
peginterferon alfa-2b combined with an anti-PD-1 antibody
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is a very early, small Phase 1 trial focused on safety and dosing, not yet on effectiveness. The combination may cause significant side effects and may not shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.