Scipibaimab Combined With Tislelizumab in Patients With First-Line Treatment-Failed Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT07388758 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-FXY-070
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the efficacy and safety of scipibaimab combined with tislelizumab in patients with recurrent or metastatic nasopharyngeal carcinoma who have progressed after first-line therapy.

Conditions

Nasopharyngeal Carcinoma (NPC)

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI)

  2 years

Secondary Outcomes (5)

• Disease control rate

  2 years

• Duration of response

  2 years

• Progression-free survival rate

  2 years

• Overall survival rate

  2 years

• Incidence rate of adverse events (AEs)

  2 years

Study Arms (1)

Scipibaimab combined with Tislelizumab

EXPERIMENTAL

Patients with recurrent or metastatic nasopharyngeal carcinoma who have progressed after first-line platinum-based chemotherapy plus PD-1 inhibition will receive scipibaimab 300 mg subcutaneous and tislelizumab 200 mg intravenous every 3 weeks until disease progression, unacceptable toxicity, or completion of 2-year treatment window.

Drug: Tislelizumab; Drug: Scipibaimab

Interventions

Tislelizumab DRUG

Anti-PD-1 targeted immunotherapy

Scipibaimab combined with Tislelizumab

Scipibaimab DRUG

Scipibaimab (CM310) is a humanized IgG4 monoclonal antibody that selectively binds to a unique epitope on human IL-4Rα, thereby simultaneously blocking IL-4 and IL-13 signaling without competing with dupilumab's binding site; it exhibits cross-species reactivity (human, cynomolgus monkey, rat), displays linear pharmacokinetics with an estimated terminal half-life of \~300 h in monkeys, and has shown favorable safety and dose-proportional exposure in multiple Phase 1-3 trials for type-2 inflammatory diseases .

Scipibaimab combined with Tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Histologically or cytologically confirmed with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with surgery and/or radiation therapy.
• \. Age ≥ 18 years and ≤ 75 years, both genders.
• \. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
• \. Life expectancy of at least 3 months.
• \. Have failed for first-line platinum-based chemotherapy.
• \. Have failed for prior treatment with PD-1 antagonists +/- chemotherapy.
• \. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.
• \. Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L; Hemoglobin ≥ 9 g/dL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN ; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L; Thyroid-stimulating hormone (TSH) levels ≤1×ULN (however, patients with free Triiodothyronine \[FT3\] or free Thyroxine \[FT4\] levels ≤1× ULN may be enrolled); INR, APTT≤1.5 x ULN.
• \. All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative.
• \. Written informed consent.

You may not qualify if:

• Known history of hypersensitivity to any components of the Tislelizumab formulation, or other monoclonal antibody.
• Prior therapy with any anti-interleukin-4 receptor α (IL-4Rα) monoclonal antibody, anti-IgE monoclonal antibody, or other monoclonal antibodies/biological agents.
• There was a history of severe bleeding, and any bleeding events with a serious grade of 3 or more in CTCAE5.0 occurred within 4 weeks before screening.
• Before treatment, MRI showed that the tumor may have invaded important blood vessels (such as enclosing the internal carotid artery / vein), nasopharyngeal necrosis, or researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during treatment.
• Patients with abnormal blood coagulation and bleeding tendency (14 days before signing informed consent: INR is within the normal range without anticoagulant); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues. On the premise that the INR \< 1.5, low-dose warfarin (1mg orally, once a day) or low-dose aspirin (daily dose not more than 100mg) is allowed for preventive purposes.
• Arteriovenous thrombosis occurred within one year before screening, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by intravenous catheterization due to early chemotherapy) and pulmonary embolism.
• \. Prior malignancy active within the previous 5 years except for locally curable cancers that have been apparently cured, such as basal cell skin cancer or carcinoma in situ of the cervix.
• \. Join another clinical study at the same time, received any research drug within 4 weeks before the first administration of the drug.
• \. Patients with any active autoimmune disease or a documented history of autoimmune disease such as pneumonia, colitis, hepatitis, nephritis, hyperthyroidism or hypothyroidism;
• \. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses \> 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration.
• \. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease.
• \. Be known to have active tuberculosis.
• \. Hepatitis B virus (HBV) \>2000 IU/ml or DNA ≥ 1×10\^4/ml; or hepatitis C virus (HCV) RNA ≥ 1×10\^3/ml).
• \. Has an active infection requiring systemic therapy.
• \. Has known active central nervous system metastases.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Sichuan Cancer Hospital and Research Institute: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (5)

• Qin S, Chan SL, Gu S, Bai Y, Ren Z, Lin X, Chen Z, Jia W, Jin Y, Guo Y, Hu X, Meng Z, Liang J, Cheng Y, Xiong J, Ren H, Yang F, Li W, Chen Y, Zeng Y, Sultanbaev A, Pazgan-Simon M, Pisetska M, Melisi D, Ponomarenko D, Osypchuk Y, Sinielnikov I, Yang TS, Liang X, Chen C, Wang L, Cheng AL, Kaseb A, Vogel A; CARES-310 Study Group. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study. Lancet. 2023 Sep 30;402(10408):1133-1146. doi: 10.1016/S0140-6736(23)00961-3. Epub 2023 Jul 24.

  PMID: 37499670 RESULT

• Zhang Y, Yan B, Shen S, Song X, Jiang Y, Shi L, Zhao C, Yang Y, Jiang L, Li J, Ye J, Liu J, Wan L, Yang Y, Chen J, Liu F, Su L, Xu Y, Tan G, Yu S, Zhang Y, Wang L, Liu S, Yan H, Liu W, Chen B, Wang C, Zhang L. Efficacy and safety of CM310 in severe eosinophilic chronic rhinosinusitis with nasal polyps (CROWNS-1): a multicentre, randomised, double-blind, placebo-controlled phase 2 clinical trial. EClinicalMedicine. 2023 Jul 5;61:102076. doi: 10.1016/j.eclinm.2023.102076. eCollection 2023 Jul.

  PMID: 37483544 RESULT

• Ng WT, Lee MC, Chang AT, Chan OS, Chan LL, Cheung FY, Hung WM, Chan CC, Lee AW. The impact of dosimetric inadequacy on treatment outcome of nasopharyngeal carcinoma with IMRT. Oral Oncol. 2014 May;50(5):506-12. doi: 10.1016/j.oraloncology.2014.01.017. Epub 2014 Feb 13.

  PMID: 24529762 RESULT

• Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

  PMID: 26808342 RESULT

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 RESULT

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Haiqiang Mai

CONTACT

86-20-87343380; maihq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Nasopharyngeal Carcinoma

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)