A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma
Trial Parameters
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Brief Summary
This study was designed to compare the efficacy and safety of YL201 with Investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma who have failed prior PD-(L)1 inhibitor and at least two lines of chemotherapy.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign a written informed consent form (ICF). 2. Aged ≥18 years and ≤75 years, male or female. 3. ECOG performance status score of 0 or 1. 4. Life expectancy ≥ 3 months. 5. Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that is not amenable to curative treatment. 6. Have failed prior treatment with PD-(L)1 inhibitors and at least two lines of chemotherapy. 7. Suitable for treatment with investigator's choice of chemotherapy (docetaxel, capecitabine, or gemcitabine). 8. At least one measurable lesion according to RECIST v1.1. 9. Subjects are willing to provide the archived or freshly obtained tumor tissue (freshly obtained or archived) for detection of B7-H3 expression 10. Adequate organ function. Exclusion Criteria: 1. History of other malignant tumors within 5 years prior to the first dose of study drug. Subjects who have been cured of other tumors by local therapy, such as basal cell carcinoma, squamous cell