NCT06629597

A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma

A Randomized, Controlled, Multicenter Phase III Clinical Study of YL201 Versus 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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to assess whether treatment with YL201 prolongs overall survival (OS) and increases objective response rate (ORR) by blinded independent central review (BICR) compared with treatment of investigator's choice of chemotherapy among subjects with recurrent or metastatic nasopharyngeal carcinoma. The secondary objectives of the study are to further evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YL201, and the correlation between B7-H3 expression level and the efficacy of YL201.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	YL201	YL201 will be administered intravenously on Day 1 of each 3-week cycle at RP3D dose level.
DRUG	Docetaxel	Docetaxel will be administered intravenously at 75 mg/m2 on Day 1 of each 3-week cycle.
DRUG	Capecitabine	Capecitabine will be administered orally at 1000 mg/m2 twice a day (BID) on Days 1 to 14 of each 3-week cycle
DRUG	Gemcitabine	Gemcitabine will be administered intravenously at 1000 mg/m2 on Day 1 and 8 of each 3-week cycle

Timeline

• Start date: 2024-12-31
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-10-08
• Last updated: 2025-02-10

Locations

1 site across 1 country: China