Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-10504 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a | Experimental |
| |
| Cohort 1b | Experimental |
| |
| Cohort 1c | Experimental |
| |
| Cohort 1d | Experimental |
| |
| Cohort 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10504 | Drug | HS-10504 administered orally every day |
|
| Measure | Description | Time Frame |
|---|---|---|
| RP2D for Combination | To evaluate the potent and tolerated of combination(s) and dosage(s) of HS-10504 based therapy in subjects with EGFR mutation-positive locally advanced or metastatic NSCLC who have experienced disease progression on or after prior treatment, which suitable for a Phase II trial | Through the full duration of this trial, approximately 2 years |
| ORR | Investigator evaluated overall response rate, to evaluate the efficacy of each combination | Through the full duration of this trial, approximately 2 years |
| TEAE | incidence of Investigator evaluated Treatment Emerged Adverse Events, graded per CTCAE V5.0 | Through the full duration of this trial, approximately 2 years |
| TRAE | incidence of Investigator evaluated Treatment Related Adverse Events, graded per CTCAE V5.0 | Through the full duration of this trial, approximately 2 years |
| SAE | incidence of Investigator evaluated Severe Adverse Events, graded per CTCAE V5.0 | Through the full duration of this trial, approximately 2 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SHR-A2009 | Drug | SHR-A2009 administered intravenously |
|
| HS-20122 | Drug | HS-20122 administered intravenously |
|
| HS-20117 | Drug | HS-20117 administered intravenously |
|
| SHR-1826 | Drug | SHR-1826 administered intravenously |
|
| SHR-A2102 | Drug | SHR-A2102 administered intravenously |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |