Actively Recruiting
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
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2025-12-02
202
Participants Needed
20
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and how the body processes a drug called YL201 when combined with Toripalimab, either with or without Cisplatin, in adults with recurrent or metastatic nasopharyngeal carcinoma. This open-label Phase Ib/II trial is conducted across multiple centers in China and focuses on patients whose cancer cannot be cured with local treatment. The study aims to better understand treatment effects in this advanced cancer setting. Treatment involves two groups: one receiving YL201 plus Toripalimab and another receiving YL201 plus Toripalimab and Cisplatin. All study drugs are given by intravenous infusion. The trial includes a dose exploration phase to assess safety and efficacy of these combinations. Participants receive treatment according to randomized assignment to one of these regimens. Participants will be monitored for side effects, cancer progression, and response to treatment over about 36 months. Researchers will assess dose-limiting toxicities, treatment-emergent adverse events, progression-free survival, and other measures such as response rate and overall survival. The study also evaluates how YL201 and its metabolites behave in the body. Participants will undergo regular medical exams, imaging, and lab tests during the study period to track outcomes and safety.
CONDITIONS
Brief Title
A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form.
- Aged 18 to 75 years, male or female.
- ECOG performance status score of 0 or 1.
- Life expectancy of at least 3 months.
- Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma not suitable for curative treatment.
- Newly diagnosed advanced nasopharyngeal carcinoma at Stage IV per AJCC 9th Edition, or recurrent disease unsuitable for local treatment.
- Systemic treatment naive for metastatic or recurrent patients.
- At least one measurable lesion by RECIST v1.1.
- Adequate organ function.
You will not qualify if you...
- History of other malignant tumors within 5 years prior to first study drug dose, except certain cured local tumors.
- Brainstem, leptomeningeal, spinal cord metastases, or spinal cord compression.
- Severe uncontrolled cardiovascular disease.
- Clinically severe respiratory impairment due to pulmonary disease.
- History or current interstitial lung disease or non-infectious pneumonitis requiring corticosteroids.
- Prior treatment with B7-H3 targeted therapy or topoisomerase I inhibitor or related ADCs.
- Prior treatment with PD-(L)1 inhibitors or related agents.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 36 months
Participants receive intravenous infusions of YL201 combined with Toripalimab, with or without Cisplatin, to evaluate safety and efficacy for recurrent or metastatic nasopharyngeal carcinoma.
Regular visits for treatment and assessments as scheduled
Trial Site Locations
Total: 20 locations
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
2
Fujian Cancer Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
3
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Not Yet Recruiting
4
Zhangzhou Municiple Hospital of Fujian Province
Zhangzhou, Fujian, China
Not Yet Recruiting
5
Dongguan People's Hospital
Dongguan, Guangdong, China
Not Yet Recruiting
6
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
7
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
8
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Not Yet Recruiting
9
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Not Yet Recruiting
10
Yuebei People's Hospital
Shaoguan, Guangdong, China
Not Yet Recruiting
11
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Not Yet Recruiting
12
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Not Yet Recruiting
13
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Not Yet Recruiting
14
Hunan Cancer Hospital
Changsha, Hunan, China
Not Yet Recruiting
15
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Not Yet Recruiting
16
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
17
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
18
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
19
Yunnan Cancer Hospital
Kunming, Yunnan, China
Not Yet Recruiting
20
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
M
MediLink Study Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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