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A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma. | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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.

NCT07258979•MediLink Therapeutics (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily sign a written informed consent form (ICF).
•2. Aged ≥18 years and ≤75 years, male or female.
•3. ECOG performance status score of 0 or 1.
•4. Life expectancy ≥ 3 months.
•5. Disease and treatment history:
•1. Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that is not amenable to curative treatment.
•2. Patients with newly diagnosed advanced nasopharyngeal carcinoma, categorized as Stage IV according to the 9th Edition of the American Joint Committee on Cancer (AJCC) Staging System; or those with recurrent nasopharyngeal carcinoma deemed unsuitable for local treatment
•3. Metastatic or recurrent patients who are systemic treatment naïve.
•6. At least one measurable lesion according to RECIST v1.1.
•7. Adequate organ function.

Exclusion Criteria

•1. History of other malignant tumors within 5 years prior to the first dose of study drug. Subjects who have been cured of other tumors by local therapy, such as basal cell carcinoma, squamous cell carcinoma of skin, bladder cancer in situ, cervical carcinoma in situ, or breast cancer in situ, are not excluded.
•2. Patients with brainstem metastases, leptomeningeal metastases, spinal cord metastases, or spinal cord compression.
•3. Patients with severe, uncontrolled cardiovascular disease.
•4. Patients with concomitant pulmonary disease resulting in clinically severe impairment of respiratory function.
•5. History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring corticosteroid therapy, OR current ILD or non-infectious pneumonitis.
•6. Prior treatment with a B7-H3 targeted therapy (including antibodies, antibody-drug conjugates \[ADCs\], CAR-T cells, and other agents), or with a topoisomerase I inhibitor or an ADC containing a topoisomerase I inhibitor payload.
•7. Prior treatment with a PD-(L)1 inhibitor (including antibodies, antibody-drug conjugates \[ADCs\], CAR-T cells, and other agents).

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

Key Dates

Start Date

November 5, 2025

Primary Completion Date

February 1, 2028

Completion Date

May 1, 2028

Last Updated

December 2, 2025

Enrollment

202

ESTIMATED participants

Conditions

Recurrent or Metastatic Nasopharyngeal Carcinoma

Interventions

YL201

DRUG

Toripalimab

DRUG

Cisplatin

DRUG

Contacts

MediLink Study Team

CONTACT

+86 512 62858368 clinicaltrials@medilinkthera.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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