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.
1. Histologically or cytologically confirmed with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with surgery and/or radiation therapy.
2. Age ≥ 18 years and ≤ 75 years, both genders.
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
4. Life expectancy of at least 3 months.
1.Known history of hypersensitivity to any components of the Tislelizumab formulation, or other monoclonal antibody.
2.Prior therapy with any anti-interleukin-4 receptor α (IL-4Rα) monoclonal antibody, anti-IgE monoclonal antibody, or other monoclonal antibodies/biological agents.
3.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.
4.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.
Single group
Tislelizumab
DrugAnti-PD-1 targeted immunotherapy
Scipibaimab
DrugScipibaimab (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 .
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)
Disease control rate
A disease control rate is defined as either a confirmed CR or a PR or a SD, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI).
Duration of response
Defined from date of first confirmed CR or a PR to date of first documentation of progression or death due to any cause, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI).
Progression-free survival rate
Defined from date of registration to date of first documentation of progression or death due to any cause.
Overall survival rate
Defined from date of registration to date of first documentation of death from any cause or censored at the date of the last follow-up.
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Sun Yat-sen University
Lead sponsor
Sichuan Cancer Hospital and Research Institute
Collaborator
Cancer Hospital of Guangxi Medical University
Collaborator
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