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.
Voluntarily sign a written informed consent form (ICF).
Aged ≥18 years and ≤75 years, male or female.
ECOG performance status score of 0 or 1.
Life expectancy ≥ 3 months.
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 carcinoma of skin, bladder cancer in situ, cervical carcinoma in situ, or breast cancer in situ, are not excluded.
Previously received B7-H3-targeted drug therapy, including antibody, antibody-drug conjugate (ADC), and chimeric antigen receptor T cell (CAR-T).
Prior treatment with a topoisomerase I inhibitor or an antibody-drug conjugate containing a topoisomerase I inhibitor.
Inadequate washout period for prior anti-tumor treatment before the first dose of study drug.
Parallel
YL201
DrugYL201 will be administered intravenously on Day 1 of each 3-week cycle at RP3D dose level.
Docetaxel
DrugDocetaxel will be administered intravenously at 75 mg/m2 on Day 1 of each 3-week cycle.
Capecitabine
DrugCapecitabine will be administered orally at 1000 mg/m2 twice a day (BID) on Days 1 to 14 of each 3-week cycle
Gemcitabine
DrugGemcitabine will be administered intravenously at 1000 mg/m2 on Day 1 and 8 of each 3-week cycle
To compare the ORR of YL201 versus investigator's choice of chemotherapy in recurrent or metastatic nasopharyngeal carcinoma assessed by BICR based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
ORR is defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR).
To compare the OS of YL201 versus investigator's choice of chemotherapy in recurrent or metastatic nasopharyngeal carcinoma.
OS defined as the time interval from the randomization to death from any cause.
To compare the ORR of YL201 versus investigator's choice of chemotherapy in recurrent or metastatic nasopharyngeal carcinoma assessed by Investigator.
ORR is defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR).
To compare the PFS of YL201 versus investigator's choice of chemotherapy in recurrent or metastatic nasopharyngeal carcinoma assessed by BICR and Investigator.
PFS defined as the time interval from randomization to the first documented PD or death due to any cause, whichever occurs first.
To compare the DOR of YL201 versus investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma assessed by BICR and Investigator.
DOR defined as the time interval from the first documentation of response (CR or PR) to the first documentation of PD or death, whichever occurred first.
To compare the DCR of YL201 versus investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma assessed by BICR and Investigator.
DCR is defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD).
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