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

Recruiting now · Phase 1/Phase 2

Conditions studied: Recurrent or Metastatic Nasopharyngeal Carcinoma

In brief

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.

Key facts

Study ID

NCT07258979

Run by

MediLink Therapeutics (Suzhou) Co., Ltd.

People needed

202

Starts

2025-11-05

Expected to finish

2028-05-01

Last updated by the study team

2025-12-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, Fujian, China
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
• Zhangzhou Municiple Hospital of Fujian Province — Zhangzhou, Fujian, China
• Dongguan People's Hospital — Dongguan, Guangdong, China
• Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guangzhou, Guangdong, China
• The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou, Guangdong, China
• Jiangmen Central Hospital — Jiangmen, Guangdong, China
• Yuebei People's Hospital — Shaoguan, Guangdong, China
• The Second Affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China
• The First Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China
• Hunan Cancer Hospital — Changsha, Hunan, China
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
• Sichuan Cancer Hospital — Chengdu, Sichuan, China
• Yunnan Cancer Hospital — Kunming, Yunnan, China
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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