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

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllMediLink Therapeutics (Suzhou) Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Voluntarily sign a written informed consent form (ICF). 2. Aged โ‰ฅ18 years and โ‰ค75 years, male or female. 3. ECOG performance status score of 0 or 1. 4. Life expectancy โ‰ฅ 3 months. 5. Disease and treatment history: 1. Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that is not amenable to curative treatment. 2. 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 3. Metastatic or recurrent patients who are systemic treatment naรฏve. 6. At least one measurable lesion according to RECIST v1.1. 7. Adequate organ function. Exclusion Criteria: 1. 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. 2. Patients with brainstem metastases, leptomeningeal metastases, spinal cord metastases, or spinal cord compression. 3. Patients with severe, uncontrolled cardiovascular disease. 4. Patients with concomitant pulmonary disease resulting in clinically severe impairment of respiratory function. 5. History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring corticosteroid therapy, OR current ILD or non-infectious pneumonitis. 6. 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. 7. Prior treatment with a PD-(L)1 inhibitor (including antibodies, antibody-drug conjugates \[ADCs\], CAR-T cells, and other agents).
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What it tests

  • YL201
  • Toripalimab
  • Cisplatin
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Where

20 sites
Chongqing University Cancer Hospital
Chongqing, China
Fujian Cancer Hospital
Fuzhou, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Zhangzhou Municiple Hospital of Fujian Province
Zhangzhou, China
Dongguan People's Hospital
Dongguan, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, China

โ€ฆand 12 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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