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This is a multicenter, open-label, phase Ib/II study of YL202 in combination with other anti-tumor therapies to Evaluate the Safety, Tolerability, and Efficacy in Patients with Advanced Solid Tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YL202 in combination with Toripalimab | Experimental | Part 1 (dose escalation stage and backfill stage) & Part 3 (dose expansion stage): YL202 for injection in combination with Toripalimab injection |
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| YL202 in combination with Furmonertinib Mesilate | Experimental | Part 2 (dose escalation stage and backfill stage) & Part 4 (dose expansion stage): YL202 for injection in combination with Furmonertinib Mesilate Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YL202 for injection; Toripalimab injection | Drug | Part 1: YL202 and Toripalimab will be administered intravenously. Part 3: participants will receive escalating doses of YL202 and fixed dose of Toripalimab until YL202 doses for optimization are determined. Dose expansion stage: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Toripalimab |
| Measure | Description | Time Frame |
|---|---|---|
| Nature and frequency of dose-limiting toxicity (DLT) | The purpose of DLT is to find maximum tolerated dose (MTD). | 21 days after the first dose was administered to each subject. |
| Nature and frequency of adverse events (AEs) | Nature and frequency of AEs with severity is aim to evaluate the safety of YL202 combination. | 42 days after the end of treatment (EOT). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR). | Up to approximately 3 years. |
| Characterize Pharmacokinetics (PK) parameter AUC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Wang, MM | Contact | +86 0512-62858368 | info@medilinkthera.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital(The First Affiliated Hospital of Ustc) | Not yet recruiting | Hefei | Anhui | 230001 | China |
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|
| YL202 for injection; Furmonertinib Mesilate Tablets | Drug | Part 2: YL202 will be administered intravenously,Furmonertinib Mesilate Tablets will be administered orally. Dose escalation stage: participants will receive escalating doses of YL202 and fixed dose of Furmonertinib Mesilate until YL202 doses for optimization are determined. Part 4: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Furmonertinib Mesilate. |
|
The area under curve: AUC is the total amount of YL217 in bloodstream after drug administration.
| Up to approximately 3 years |
| Characterize Pharmacokinetics (PK) parameter Cmax | Maximum concentration: The highest measured concentration of YL217 in the bloodstream. | Up to approximately 3 years |
| Characterize Pharmacokinetics (PK) parameter Ctrough | Trough concentration | Up to approximately 3 years |
| Characterize Pharmacokinetics (PK) parameter Tmax | Time to maximum observed concentration | Up to approximately 3 years |
| Characterize Pharmacokinetics (PK) parameter CL | Clearance: defined as the amount of drug removed from the bloodstream by the body per unit of time | Up to approximately 3 years |
| Characterize Pharmacokinetics (PK) parameter Vd | volume of distribution | Up to approximately 3 years |
| Characterize Pharmacokinetics (PK) parameter t1/2 | Half-life time:defined as the time it takes for the concentration of the drug in plasma or serum to be reduced by 50% | Up to approximately 3 years |
| Immunogenicity endpoint: Incidence of anti-YL202 antibody (ADAs). | The presence of ADAs in patients treated with YL202 will be assessed to evaluate immunogenicity. | Up to approximately 3 years |
| Fujian Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350014 | China |
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| Sun Yat-sen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | 510555 | China |
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| Meizhou People's Hospital(Huangtang Hospital)Meizhou Academy of Medical Sciences | Not yet recruiting | Meizhou | Guangdong | 514031 | China |
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| Ghang xi Medical University Cancer Hospital | Not yet recruiting | Nanning | Guangxi | 530028 | China |
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| Affiliated Hospital Of Hebei University | Not yet recruiting | Baoding | Hebei | 71051 | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
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| Anyang Cancer Hospital | Not yet recruiting | Anyang | Henan | 455100 | China |
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| The First Affiliated Hospital of Henan University of Science and Technology | Not yet recruiting | Luoyang | Henan | 471023 | China |
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| Xiangyang Central Hospital | Not yet recruiting | Xiangyang | Hubei | 441138 | China |
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| The First People's Hospital of Changde City | Not yet recruiting | Changde | Hunan | 415000 | China |
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| Jiangsu Province Hospital(The First Affiliated Hospital With Nanjing Medical University, Jiangsu Women And Children Health Hospital) | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
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| Jiangxi Cancer Hospital | Not yet recruiting | Nanchang | Jiangxi | China |
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| Affiliated Zhongshan Hospital Dalian University | Not yet recruiting | Dalian | Liaoning | 116001 | China |
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| Liaoning cancer hospital &institute | Not yet recruiting | Shenyang | Liaoning | 110042 | China |
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| Affiliated Zhongshan Hospital Dalian University | Not yet recruiting | Jinan | Shandong | 250117 | China |
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| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 201321 | China |
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| Shanxi Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | 30013 | China |
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| Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital | Not yet recruiting | Sichuan | Sichuan | 610072 | China |
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| Tianjin Cancer Hospital Airport Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300300 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| C000656314 | toripalimab |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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