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.
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.
Patients with brainstem metastases, leptomeningeal metastases, spinal cord metastases, or spinal cord compression.
Patients with severe, uncontrolled cardiovascular disease.
Patients with concomitant pulmonary disease resulting in clinically severe impairment of respiratory function.
Single group
YL201
DrugYL201 will be administered as an IV infusion
Toripalimab
DrugToripalimab will be administered as an IV infusion
Cisplatin
DrugCisplatin will be administered as an IV infusion
Number of Participants Experiencing Dose-limiting toxicities (DLTs)
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Progression-Free Survival (PFS) as assessed by RECIST v1.1
Objective Response Rate (ORR)
Disease Control Rate (DCR)
Time to Response (TTR)
Duration of Response (DoR)
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