Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic NPC After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial

NCT ID: NCT07101744

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-17
• Study Completion Date: 2030-07-16

Brief 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). 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

Conditions

Nasopharyngeal Carcinoma (NPC); First-line Treatment Failure Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Iparomlimab and Tuvonralimab

Intervention Type: DRUG

Iparomlimab and Tuvonralimab combined with Nimotuzumab , administered on Day 1 every 3 weeks (D1 Q3W), until disease progression or unacceptable toxicity.

Interventions

Iparomlimab and Tuvonralimab

Iparomlimab and Tuvonralimab combined with Nimotuzumab , administered on Day 1 every 3 weeks (D1 Q3W), until disease progression or unacceptable toxicity.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Fei Han

Principal lnvestigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangdong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

hui xiao wang, Ph.D. (Doctor of Philosophy)

Role: CONTACT

wangxh@sysucc.org.cn

86+18826260661

fei han, Ph.D. (Doctor of Philosophy)

Role: CONTACT

hanfei@sysucc.org.cn

86+13822113698

Facility Contacts

fei han, M.D.

Role: primary

hanfei@sysucc.org.cn

+86 1382211369

hui xiao wang, M.D.

Role: backup

Other Identifiers

B2025-381-01

Identifier Type: -

Identifier Source: org_study_id