Actively Recruiting
A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2025-12-02
202
Participants Needed
20
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
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Voluntarily sign a written informed consent form (ICF).
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Aged ≥18 years and ≤75 years, male or female.
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ECOG performance status score of 0 or 1.
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Life expectancy ≥ 3 months.
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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.
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At least one measurable lesion according to RECIST v1.1.
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Adequate organ function.
You will not qualify if you...
- 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).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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