Scipibaimab Combined With Tislelizumab in Patients With First-Line Treatment-Failed Recurrent/Met… (NCT07388758) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Scipibaimab Combined With Tislelizumab in Patients With First-Line Treatment-Failed Recurrent/Metastatic Nasopharyngeal Carcinoma
China37 participantsStarted 2026-02
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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.
* 5\. Have failed for first-line platinum-based chemotherapy.
* 6\. Have failed for prior treatment with PD-1 antagonists +/- chemotherapy.
* 7\. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.
* 8\. 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.
* 9\. All women with fertility potential must undergo a urine or serum pregnancy …