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.
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Sichuan Cancer Hospital
NOT_YET_RECRUITING
Chengdu
Chongqing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
Dongguan People's Hospital
NOT_YET_RECRUITING
Dongguan
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital of Guangdong Pharmaceutical University
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated Hospital of Guilin Medical University
NOT_YET_RECRUITING
Guilin
The First Affiliated Hospital of Hainan Medical University
NOT_YET_RECRUITING
Haikou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Jiangmen Central Hospital
NOT_YET_RECRUITING
Jiangmen
Yunnan Cancer Hospital
NOT_YET_RECRUITING
Kunming
Jiangxi Cancer Hospital
NOT_YET_RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING
Nanning
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
Yuebei People's Hospital
NOT_YET_RECRUITING
Shaoguan
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Zhangzhou Municiple Hospital of Fujian Province
NOT_YET_RECRUITING
Zhangzhou
Contact Information
Primary
MediLink Study Team
clinicaltrials@medilinkthera.com
+86 512 62858368
Time Frame
Start Date:2025-11-05
Estimated Completion Date:2028-05
Participants
Target number of participants:202
Treatments
Experimental: Dose Exploration (Part 1)
To evaluate the safety and efficacy of YL201 combined with Toripalimab in subjects with recurrent or metastatic nasopharyngeal carcinoma
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.