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RECRUITING
NCT06629597
PHASE3

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

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2024-12-31

Completion Date

2028-12-01

Last Updated

2025-02-10

Healthy Volunteers

No

Interventions

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China