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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Exploration (Part 1) | Experimental | To evaluate the safety and efficacy of YL201 combined with Toripalimab in subjects with recurrent or metastatic nasopharyngeal carcinoma |
|
| Dose Exploration (Part 2) | Experimental | To evaluate the safety and efficacy of YL201 combined with Toripalimab with/without Cisplatin in subjects with recurrent or metastatic nasopharyngeal carcinoma. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YL201 | Drug | YL201 will be administered as an IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Dose-limiting toxicities (DLTs) | Approximately within 36 months | |
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Approximately within 36 months | |
| Progression-Free Survival (PFS) as assessed by RECIST v1.1 | Approximately within 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Approximately within 36 months | |
| Disease Control Rate (DCR) | Approximately within 36 months | |
| Time to Response (TTR) |
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Inclusion Criteria:
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:
At least one measurable lesion according to RECIST v1.1.
Adequate organ function.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MediLink Study Team | Contact | +86 512 62858368 | clinicaltrials@medilinkthera.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing University Cancer Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | China |
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| Toripalimab | Drug | Toripalimab will be administered as an IV infusion |
|
| Cisplatin | Drug | Cisplatin will be administered as an IV infusion |
|
| Approximately within 36 months |
| Duration of Response (DoR) | Approximately within 36 months |
| Overall survival(OS) | Approximately within 36 months |
| Incidence of anti-drug antibodies (ADA) to YL201 (and to Toripalimab, if necessary) | Approximately within 36 months |
| Characterize the PK parameter AUC of YL201 and its metabolites, if applicable | Approximately within 36 months |
| Characterize the PK parameter Cmax of YL201 and its metabolites, if applicable | Approximately within 36 months |
| Characterize the PK parameter Ctrough of YL201 and its metabolites, if applicable | Approximately within 36 months |
| Characterize the PK parameter t1/2 of YL201 and its metabolites, if applicable | Approximately within 36 months |
| Fujian Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | China |
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| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | China |
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| Zhangzhou Municiple Hospital of Fujian Province | Not yet recruiting | Zhangzhou | Fujian | China |
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| Dongguan People's Hospital | Not yet recruiting | Dongguan | Guangdong | China |
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| Affiliated Cancer Hospital and Institute of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
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| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
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| The First Affiliated Hospital of Guangdong Pharmaceutical University | Not yet recruiting | Guangzhou | Guangdong | China |
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| Jiangmen Central Hospital | Not yet recruiting | Jiangmen | Guangdong | China |
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| Yuebei People's Hospital | Not yet recruiting | Shaoguan | Guangdong | China |
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| The Second Affiliated Hospital of Guilin Medical University | Not yet recruiting | Guilin | Guangxi | China |
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| Guangxi Medical University Cancer Hospital | Not yet recruiting | Nanning | Guangxi | China |
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| The First Affiliated Hospital of Hainan Medical University | Not yet recruiting | Haikou | Hainan | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | China |
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| Jiangxi Cancer Hospital | Not yet recruiting | Nanchang | Jiangxi | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | China |
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| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Sichuan Cancer Hospital | Not yet recruiting | Chengdu | Sichuan | China |
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| Yunnan Cancer Hospital | Not yet recruiting | Kunming | Yunnan | China |
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| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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