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.
In the immunotherapy era, patients with recurrent/metastatic nasopharyngeal carcinoma who progress after both platinum-based chemotherapy and PD-1 blockade lack further standard options. IL-4Rα inhibition can overcome PD-1 resistance by re-activating CD8+ T cells; combining scipibaimab (anti-IL-4Rα) with tislelizumab (anti-PD-1) has shown additive activity without overlapping toxicity. This trial will assess the efficacy and safety of the combination in patients who have failed prior platinum and PD-1 therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Anti-PD-1 targeted immunotherapy
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 .
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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)
Time frame: 2 years
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).
Time frame: 2 years
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).
Time frame: 2 years
Progression-free survival rate
Defined from date of registration to date of first documentation of progression or death due to any cause.
Time frame: 2 years
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.
Time frame: 2 years
Incidence rate of adverse events (AEs)
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events (acute toxicity) as assessed by CTCAE v5.0.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.