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.

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent or Metastatic Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: YL201; Drug: Toripalimab; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Estimated): 202
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: MediLink Study Team; Phone Number: +86 512 62858368; Email: clinicaltrials@medilinkthera.com

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Not yet recruiting
      • Chongqing University Cancer Hospital
      • Contact: Study Coordinator
  • Fujian
    • Fuzhou, Fujian, China
      • Not yet recruiting
      • Fujian Cancer Hospital
      • Contact: Study Coordinator
    • Xiamen, Fujian, China
      • Not yet recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Study Coordinator
    • Zhangzhou, Fujian, China
      • Not yet recruiting
      • Zhangzhou Municiple Hospital of Fujian Province
      • Contact: Study Coordinator
  • Guangdong
    • Dongguan, Guangdong, China
      • Not yet recruiting
      • Dongguan People's Hospital
      • Contact: Study Coordinator
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Study Coordinator
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • The First Affiliated Hospital of Guangdong Pharmaceutical University
      • Contact: Study Coordinator
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
      • Contact: Study Coordinator
    • Jiangmen, Guangdong, China
      • Not yet recruiting
      • Jiangmen Central Hospital
      • Contact: Study Coordinator
    • Shaoguan, Guangdong, China
      • Not yet recruiting
      • Yuebei People's Hospital
      • Contact: Study Coordinator
  • Guangxi
    • Guilin, Guangxi, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Guilin Medical University
      • Contact: Study Coordinator
    • Nanning, Guangxi, China
      • Not yet recruiting
      • Guangxi Medical University Cancer Hospital
      • Contact: Study Coordinator
  • Hainan
    • Haikou, Hainan, China
      • Not yet recruiting
      • The First Affiliated Hospital of Hainan Medical University
      • Contact: Study Coordinator
  • Hunan
    • Changsha, Hunan, China
      • Not yet recruiting
      • Hunan Cancer Hospital
      • Contact: Study Coordinator
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Not yet recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Study Coordinator
    • Nanchang, Jiangxi, China
      • Not yet recruiting
      • Jiangxi Cancer Hospital
      • Contact: Study Coordinator
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Not yet recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Study Coordinator
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • Sichuan Cancer Hospital
      • Contact: Study Coordinator
  • Yunnan
    • Kunming, Yunnan, China
      • Not yet recruiting
      • Yunnan Cancer Hospital
      • Contact: Study Coordinator
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Zhejiang Cancer Hospital
      • Contact: Study Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Exploration (Part 1); To evaluate the safety and efficacy of YL201 combined with Toripalimab in subjects with recurrent or metastatic nasopharyngeal carcinoma	Drug: YL201; YL201 will be administered as an IV infusion; Drug: Toripalimab; Toripalimab will be administered as an IV infusion
Experimental: Dose Exploration (Part 2); To evaluate the safety and efficacy of YL201 combined with Toripalimab with/without Cisplatin in subjects with recurrent or metastatic nasopharyngeal carcinoma.	Drug: YL201; YL201 will be administered as an IV infusion; Drug: Toripalimab; Toripalimab will be administered as an IV infusion; Drug: Cisplatin; Cisplatin will be administered as an IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Experiencing Dose-limiting toxicities (DLTs)	Approximately within 36 months
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Approximately within 36 months
Progression-Free Survival (PFS) as assessed by RECIST v1.1	Approximately within 36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR)	Approximately within 36 months
Disease Control Rate (DCR)	Approximately within 36 months
Time to Response (TTR)	Approximately within 36 months
Duration of Response (DoR)	Approximately within 36 months
Overall survival(OS)	Approximately within 36 months
Incidence of anti-drug antibodies (ADA) to YL201 (and to Toripalimab, if necessary)	Approximately within 36 months
Characterize the PK parameter AUC of YL201 and its metabolites, if applicable	Approximately within 36 months
Characterize the PK parameter Cmax of YL201 and its metabolites, if applicable	Approximately within 36 months
Characterize the PK parameter Ctrough of YL201 and its metabolites, if applicable	Approximately within 36 months
Characterize the PK parameter t1/2 of YL201 and its metabolites, if applicable	Approximately within 36 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Toripalimab; YL201; recurrent or metastatic nasopharyngeal carcinoma
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Pathological Conditions, Signs and Symptoms; Nasopharyngeal Carcinoma; Recurrence; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Cisplatin; toripalimab
• Other Study ID Numbers: YL201-CN-105-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No