Nasopharyngeal Carcinoma (NPC)Phase 2NCT07101744
Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic NPC After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial
A Phase 2 study testing Iparomlimab and Tuvonralimab in people with Nasopharyngeal Carcinoma (NPC) and First-line Treatment Failure Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to preliminarily explore the efficacy and safety of Iparomlimab and Tuvonralimab in combination with Nimotuzumab for the treatment of recurrent/metastatic nasopharyngeal carcinoma (NPC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC), First-line Treatment Failure Nasopharyngeal Carcinoma
- What is being tested?
- Iparomlimab and Tuvonralimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2025to 16 Jul 2030
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status score of 0-1;
- Age 18 to 70 years;
- Histologically confirmed nasopharyngeal carcinoma;
- 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);
- Availability of nasopharyngeal + neck MRI data prior to enrollment, with at least one measurable lesion (excluding bone metastases);
- Willingness to provide archived tumor tissue specimens or undergo a biopsy to collect tumor tissue for PD-L1 expression level testing;
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- 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.
- Voluntary participation with signed informed consent form.
Who cannot join
- History of other malignancies (except adequately treated non-melanoma skin cancer, in situ carcinoma, or other cancers cured ≥5 years prior);
- Comorbidities requiring long-term immunosuppressive therapy or systemic/local corticosteroids at immunocompromising doses;
- Immunodeficiency diseases or history of organ transplantation (including but not limited to: interstitial pneumonia, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.);
- HIV-positive status; HBsAg-positive with detectable HBV DNA ≥1000 copies/mL; or HCV antibody-positive;
- High-dose glucocorticoid use within 4 weeks prior;
- Pregnant/lactating women or individuals of reproductive potential without effective contraception;
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- Laboratory test abnormalities beyond protocol-defined thresholds within 7 days before enrollment;
- Significant impairment of cardiac, hepatic, pulmonary, renal, or bone marrow function;
- Uncontrolled comorbidities or active infections;
- Concurrent participation in other clinical trials or receipt of investigational drugs;
- Unwillingness or inability to provide written informed consent;
- Other contraindications to study treatment;
- Psychiatric disorders or cognitive impairment limiting legal competency.
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, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangdong
fei han, M.D., +86 1382211369, hanfei@sysucc.org.cn
hui xiao wang, M.D.
About this study
Official title: Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic Nasopharyngeal Carcinoma After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial
This study aims to preliminarily explore the efficacy and safety of Iparomlimab and Tuvonralimab in combination with Nimotuzumab for the treatment of recurrent/metastatic nasopharyngeal carcinoma (NPC). It is expected to investigate a novel therapeutic regimen with improved efficacy and enhanced safety for recurrent/metastatic NPC, thereby providing robust evidence-based medical support for the application of dual-target immune checkpoint inhibitors in nasopharyngeal carcinoma therapy
- Being tested
- Iparomlimab and Tuvonralimab
- Keywords
- Nasopharyngeal Carcinoma (NPC), Nimotuzumab, Iparomlimab and Tuvonralimab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and TuvonralimabDrug
Iparomlimab and Tuvonralimab combined with Nimotuzumab , administered on Day 1 every 3 weeks (D1 Q3W), until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Iparomlimab and Tuvonralimab combined with Nimotuzumab , administered on Day 1 every 3 weeks (D1 Q3W), until disease progression or unacceptable toxicity，or for a maximum of one year Receives: Drug: Iparomlimab and Tuvonralimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Secondary outcomes (1)
2-Year Progression-Free Survival Rate (PFS)
2-year failure free survival time from the randomization to the first treatment failure or death
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start17 Oct 2025
- Primary completion16 Jul 2028 (estimated)
- Study completion16 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Han, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101744
- Sponsor's protocol ID
- B2025-381-01
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic Nasopharyngeal Carcinoma After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial
- ClinicalTrials.gov ID
- NCT07101744
- Acronym / sponsor ID
- B2025-381-01
- Keywords
- Nasopharyngeal Carcinoma (NPC), Nimotuzumab, Iparomlimab and Tuvonralimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 16 Jul 2028 (estimated)
- Study completion
- 16 Jul 2030 (estimated)
- First posted
- 3 Aug 2025 (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 aims to preliminarily explore the efficacy and safety of Iparomlimab and Tuvonralimab in combination with Nimotuzumab for the treatment of recurrent/metastatic nasopharyngeal carcinoma (NPC). It is expected to investigate a novel therapeutic regimen with improved efficacy and enhanced safety for recurrent/metastatic NPC, thereby providing robust evidence-based medical support for the application of dual-target immune checkpoint inhibitors in nasopharyngeal carcinoma therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Iparomlimab and TuvonralimabIparomlimab and Tuvonralimab combined with Nimotuzumab , administered on Day 1 every 3 weeks (D1 Q3W), until disease progression or unacceptable toxicity，or for a maximum of one year |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ECOG performance status score of 0-1;
- Age 18 to 70 years;
- Histologically confirmed nasopharyngeal carcinoma;
- 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);
- Availability of nasopharyngeal + neck MRI data prior to enrollment, with at least one measurable lesion (excluding bone metastases);
Key exclusion criteria (13 listed)
- History of other malignancies (except adequately treated non-melanoma skin cancer, in situ carcinoma, or other cancers cured ≥5 years prior);
- Comorbidities requiring long-term immunosuppressive therapy or systemic/local corticosteroids at immunocompromising doses;
- Immunodeficiency diseases or history of organ transplantation (including but not limited to: interstitial pneumonia, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.);
- HIV-positive status; HBsAg-positive with detectable HBV DNA ≥1000 copies/mL; or HCV antibody-positive;
- High-dose glucocorticoid use within 4 weeks prior;
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 |
|---|---|---|
| Iparomlimab and TuvonralimabIparomlimab and Tuvonralimab combined with Nimotuzumab , administered on Day 1 every 3 weeks (D1 Q3W), until disease progression or unacceptable toxicity. | Drug | Experimental group |
Primary outcome
Objective Response Rate (ORR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
1 secondary outcome
2-Year Progression-Free Survival Rate (PFS)
Time frame: 2-year
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 23 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvonralimab in people with Nasopharyngeal Carcinoma (NPC) and First-line Treatment Failure Nasopharyngeal Carcinoma, run by Sun Yat-sen 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 11 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 23 Jan 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 hui xiao wang, Ph.D. (Doctor of Philosophy) (86+18826260661, wangxh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years). 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 23 Jan 2026.