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The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combined with other antitumor therapies in subjects with locally advanced or metastatic non-small cell lung cancer; Evaluate the pharmacokinetic (PK) characteristics of HRS-4508 and other efficacy endpoints for the treatment of locally advanced or metastatic non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A/B/C | Experimental | PartA:HRS-4508 tablet+SHR-A1811 PartB:HRS-4508 tablet+ Adebrelimab Injection PartC:HRS-4508 tablet+SHR-A1811+ Adebrelimab Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4508 tablet | Drug | PartA :HRS-4508 tablet fixed dose+SHR-A1811 fixed dose PartB:HRS-4508 tablet fixed dose + Adebrelimab Injection fixed dose PartC:HRS-4508 tablet fixed dose +SHR-A1811 fixed dose + Adebrelimab Injection fixed dose |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | 2 month | |
| Maximum tolerated dose (MTD) | 2 month | |
| Determine dose recommendation (RP2D) | 6month | |
| The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) | 1 years | |
| Objective response rate (ORR) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentrations of HRS-4508 and SHR-A1811 | 12 weeks | |
| Duration of response (DoR) | 1 year | |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liju Zong | Contact | +86-15821860817 | liju.zong@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200430 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 1 year |
| Progression free survival (PFS) | 1 year |
| Overall survival (OS) | 2 year |
| Zhejiang Tumor Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |