This is a multicenter, open-label, Phase Ib/II study conducted in China to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of YL201 combined with Toripalimab (doublet regimen) or YL201 combined with Toripalimab and Cisplatin (triplet regimen) in subjects with recurrent or metastatic nasopharyngeal carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
YL201 will be administered as an IV infusion
Toripalimab will be administered as an IV infusion
Cisplatin will be administered as an IV infusion
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Number of Participants Experiencing Dose-limiting toxicities (DLTs)
Time frame: Approximately within 36 months
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Approximately within 36 months
Progression-Free Survival (PFS) as assessed by RECIST v1.1
Time frame: Approximately within 36 months
Objective Response Rate (ORR)
Time frame: Approximately within 36 months
Disease Control Rate (DCR)
Time frame: Approximately within 36 months
Time to Response (TTR)
Time frame: Approximately within 36 months
Duration of Response (DoR)
Time frame: Approximately within 36 months
Overall survival(OS)
Time frame: Approximately within 36 months
Incidence of anti-drug antibodies (ADA) to YL201 (and to Toripalimab, if necessary)
Time frame: Approximately within 36 months
Characterize the PK parameter AUC of YL201 and its metabolites, if applicable
Time frame: Approximately within 36 months
Characterize the PK parameter Cmax of YL201 and its metabolites, if applicable
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Fujian Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGZhangzhou Municiple Hospital of Fujian Province
Zhangzhou, Fujian, China
NOT_YET_RECRUITINGDongguan People's Hospital
Dongguan, Guangdong, China
NOT_YET_RECRUITINGAffiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGJiangmen Central Hospital
Jiangmen, Guangdong, China
NOT_YET_RECRUITINGYuebei People's Hospital
Shaoguan, Guangdong, China
NOT_YET_RECRUITING...and 10 more locations
Time frame: Approximately within 36 months
Characterize the PK parameter Ctrough of YL201 and its metabolites, if applicable
Time frame: Approximately within 36 months
Characterize the PK parameter t1/2 of YL201 and its metabolites, if applicable
Time frame: Approximately within 36 months