New immune combo targets hard-to-treat nose and throat cancer
NCT ID NCT07101744
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of two immune-boosting drugs (iparomlimab and tuvonralimab) plus a targeted antibody (nimotuzumab) in people with advanced nasopharyngeal cancer that got worse after standard first treatment. About 41 adults aged 18-70 will receive the therapy to see if it shrinks tumors and how safe it is. The goal is to find a better option for this tough-to-treat cancer.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 41 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. ECOG performance status score of 0-1; 2. Age 18 to 70 years; 3. Histologically confirmed nasopharyngeal carcinoma; 4. Patients with locoregional recurrence unsuitable for surgery or radiotherapy, or those who developed distant metastasis after standard comprehensive treatment, or initially diagnosed with metastatic nasopharyngeal carcinoma, provided they have experienced treatment failure with first-line cisplatin-based regimens (± PD-1 monoclonal antibody); 5. Availability of nasopharyngeal + neck MRI data prior to enrollment, with at least one measurable lesion (excluding bone metastases); 6. Willingness to provide archived tumor tissue specimens or undergo a biopsy to collect tumor tissue for PD-L1 expression level testing; 7. Laboratory test results within 7 days prior to enrollment meeting the following criteria: Hematology: Absolute neutrophil count (ANC) ≥ 2.0 × 10\^9/L, hemoglobin (Hb) ≥ 9.0 g/dL, platelets (PLT) ≥ 100 × 10\^9/L; Liver function: Total bilirubin \< 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 1.5 × ULN; Renal function: Serum creatinine \< 1.5 × ULN. 8. Voluntary participation with signed informed consent form. Exclusion Criteria: 1. History of other malignancies (except adequately treated non-melanoma skin cancer, in situ carcinoma, or other cancers cured ≥5 years prior); 2. Comorbidities requiring long-term immunosuppressive therapy or systemic/local corticosteroids at immunocompromising doses; 3. Immunodeficiency diseases or history of organ transplantation (including but not limited to: interstitial pneumonia, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.); 4. HIV-positive status; HBsAg-positive with detectable HBV DNA ≥1000 copies/mL; or HCV antibody-positive; 5. High-dose glucocorticoid use within 4 weeks prior; 6. Pregnant/lactating women or individuals of reproductive potential without effective contraception; 7. Laboratory test abnormalities beyond protocol-defined thresholds within 7 days before enrollment; 8. Significant impairment of cardiac, hepatic, pulmonary, renal, or bone marrow function; 9. Uncontrolled comorbidities or active infections; 10. Concurrent participation in other clinical trials or receipt of investigational drugs; 11. Unwillingness or inability to provide written informed consent; 12. Other contraindications to study treatment; 13. Psychiatric disorders or cognitive impairment limiting legal competency.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sun Yat-sen University Cancer Center
RECRUITINGGuangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Experimental infusion drug tested against recurrent nasopharyngeal cancer
- DNA blood test may spot nasopharyngeal cancer earlier than current methods
- Million-Person quest to catch a silent cancer early
- Can a new drug combo shrink High-Risk throat tumors?
- Can a lower radiation dose still beat nasopharyngeal cancer?