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

NCT06629597 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-02-10

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma

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

Sponsors & Collaborators

  • MediLink Therapeutics (Suzhou) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2027-12-01
Completion
2028-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06629597 on ClinicalTrials.gov