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

NCT07258979 | Recruiting Phase 1

• 1 other identifier: YL201-CN-105-02
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Recurrent or Metastatic Nasopharyngeal Carcinoma

Keywords

YL201; recurrent or metastatic nasopharyngeal carcinoma; Toripalimab

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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

Study Arms (2)

Dose Exploration (Part 1)

EXPERIMENTAL

To evaluate the safety and efficacy of YL201 combined with Toripalimab in subjects with recurrent or metastatic nasopharyngeal carcinoma

Drug: YL201; Drug: Toripalimab

Dose Exploration (Part 2)

EXPERIMENTAL

To evaluate the safety and efficacy of YL201 combined with Toripalimab with/without Cisplatin in subjects with recurrent or metastatic nasopharyngeal carcinoma.

Drug: YL201; Drug: Toripalimab; Drug: Cisplatin

Interventions

YL201 DRUG

YL201 will be administered as an IV infusion

Dose Exploration (Part 1); Dose Exploration (Part 2)

Toripalimab DRUG

Toripalimab will be administered as an IV infusion

Dose Exploration (Part 1); Dose Exploration (Part 2)

Cisplatin DRUG

Cisplatin will be administered as an IV infusion

Dose Exploration (Part 2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign a written informed consent form (ICF).
• Aged ≥18 years and ≤75 years, male or female.
• ECOG performance status score of 0 or 1.
• Life expectancy ≥ 3 months.
• Disease and treatment history:
• Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that is not amenable to curative treatment.
• 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
• Metastatic or recurrent patients who are systemic treatment naïve.
• At least one measurable lesion according to RECIST v1.1.
• Adequate organ function.

You may not qualify if:

• 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.
• Patients with brainstem metastases, leptomeningeal metastases, spinal cord metastases, or spinal cord compression.
• Patients with severe, uncontrolled cardiovascular disease.
• Patients with concomitant pulmonary disease resulting in clinically severe impairment of respiratory function.
• History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring corticosteroid therapy, OR current ILD or non-infectious pneumonitis.
• 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.
• Prior treatment with a PD-(L)1 inhibitor (including antibodies, antibody-drug conjugates \[ADCs\], CAR-T cells, and other agents).

Sponsors & Collaborators

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

Study Sites (20)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

NOT YET RECRUITING

Zhangzhou Municiple Hospital of Fujian Province

Zhangzhou, Fujian, China

NOT YET RECRUITING

Dongguan People's Hospital

Dongguan, Guangdong, China

NOT YET RECRUITING

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Jiangmen Central Hospital

Jiangmen, Guangdong, China

NOT YET RECRUITING

Yuebei People's Hospital

Shaoguan, Guangdong, China

NOT YET RECRUITING

The Second Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

NOT YET RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

NOT YET RECRUITING

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

NOT YET RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, China

NOT YET RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

NOT YET RECRUITING

MeSH Terms

Conditions

Recurrence; Nasopharyngeal Carcinoma

Interventions

toripalimab; Cisplatin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

MediLink Study Team

CONTACT

+86 512 62858368; clinicaltrials@medilinkthera.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 2, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (20)