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Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in combination with other anti-tumor treatments in lung cancer subjects, and determine the recommended dose (RP2D) and initial efficacy for phase II clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental |
| |
| Part B | Experimental |
| |
| Part C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin | Drug | FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT (Dose-limiting toxicity):Severe toxicity occurred 21 or 28 days after each subject received their first systemic anticancer treatment. | 21or28 days after the first administration of each subject | |
| Incidence of Treatment-Emergent Adverse Events | from first dose to disease progression or death, up to 3 years. | |
| RP2D (Recommended Phase II Dose):This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics. | This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics. | from first dose to disease progression or death, up to 3 years |
| ORR (Objective Response Rate) | The proportion of patients whose tumor volume shrank to the pre-defined standard (complete or partial response) after treatment. | from first dose to disease progression or death, whichever comes first, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DoR) | from first dose to disease progression or death, whichever comes first, up to 3 years | |
| disease control rate (DCR) | from first dose to disease progression or death, whichever comes first, up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaouxe Pi | Contact | 0518-82342973 | Xiaoxue.pi@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| FH-006 ; SHR-1316 ; BP102 | Drug | FH-006 ; SHR-1316 ; BP102 |
|
| FH-006; SHR-1316 ; SHR-8068 | Drug | FH-006; SHR-1316 ; SHR-8068 |
|
| progression free survival (PFS) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| overall survival (OS) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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