RecruitingPhase 3NCT06629597

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


Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Enrollment

400 participants

Start Date

Dec 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase III study is testing a new antibody-drug treatment called YL201 in people with nasopharyngeal carcinoma (a type of cancer in the back of the nose/throat) that has come back or spread, and has stopped responding to standard treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed recurrent or metastatic nasopharyngeal carcinoma - Your cancer has already failed treatment with immunotherapy and at least two rounds of chemotherapy - You have at least one measurable tumor on scans - Your overall health is good (ECOG 0 or 1) **You may NOT be eligible if...** - You have had another cancer in the past 5 years - You have previously received B7-H3-targeted therapy - You have active brain, spinal cord, or meningeal metastases - You have active hepatitis B, hepatitis C, or HIV - You are pregnant or breastfeeding - You have active autoimmune disease requiring ongoing treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGYL201

YL201 will be administered intravenously on Day 1 of each 3-week cycle at RP3D dose level.

DRUGDocetaxel

Docetaxel will be administered intravenously at 75 mg/m2 on Day 1 of each 3-week cycle.

DRUGCapecitabine

Capecitabine will be administered orally at 1000 mg/m2 twice a day (BID) on Days 1 to 14 of each 3-week cycle

DRUGGemcitabine

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

View Full Details on ClinicalTrials.gov

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NCT06629597


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