RecruitingPhase 1Phase 2NCT07258979

A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.

A Multicenter, Open-label, Phase Ib/II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 Combined With Toripalimab, With or Without Cisplatin, in Subjects With Recurrent or Metastatic Nasopharyngeal Carcinoma.

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Enrollment

202 participants

Start Date

Nov 5, 2025

Study Type

INTERVENTIONAL

Conditions

Recurrent or Metastatic Nasopharyngeal Carcinoma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called YL201 combined with toripalimab (an immunotherapy drug) with or without cisplatin (a chemotherapy drug) for people with nasopharyngeal carcinoma — a type of cancer in the upper part of the throat, behind the nose. **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed diagnosis of recurrent or metastatic nasopharyngeal carcinoma - You are in reasonably good physical condition (able to carry out daily activities) - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have serious heart, lung, liver, or kidney problems - You have active autoimmune disease or are on immune-suppressing medication - You have had prior treatment that disqualifies you under study criteria 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 as an IV infusion

DRUGToripalimab

Toripalimab will be administered as an IV infusion

DRUGCisplatin

Cisplatin will be administered as an IV infusion

Locations(20)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Zhangzhou Municiple Hospital of Fujian Province

Zhangzhou, Fujian, China

Dongguan People's Hospital

Dongguan, Guangdong, China

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Yuebei People's Hospital

Shaoguan, Guangdong, China

The Second Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07258979

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