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This is a Phase I clinical study of HS-20093. The purpose of this study is to evaluate the safety, tolerability, PK and efficacy of HS-20093 in combination with Adebrelimab in patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
This is a multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, PK and efficacy of HS-20093 in combination with Adebrelimab in patients with ES-SCLC. Patients with ES-SCLC without disease progression after receiving first-line standard induction therapy (Platinum + Etoposide +PD- (L) 1 inhibitor combination therapy) will receive maintenance therapy of HS-20093 in combination with Adebrelimab. Patients will continue treatment until disease progression or other criteria for termination of treatment are met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-20093 and Adebrelimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20093 in combination with Adebrelimab | Drug | HS-20093 in combination with Adebrelimab will be administered intravenously every 3 weeks until disease progression or other criteria for termination of treatment are met. |
| Measure | Description | Time Frame |
|---|---|---|
| Pogression-free survival (PFS) determined by investigators according to RECIST 1.1 | PFS is deļ¬ned as the time from date of ļ¬rst dose until the documentation of objective PD or death from any cause in the absence of progression (whichever occurred first), regardless of whether they subsequently received non-study anti-cancer therapy. | up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered an investigational product, which may present with symptoms, signs, disease, or laboratory abnormalities, but do not necessarily have a causality with the investigational product. | From the first dose through 90 days post end of treatment |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
Exclusion Criteria:
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| Objective response rate (ORR) assessed by investigator | ORR is defined as the percentage of patients with a CR or PR that is confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1 | up to approximately 24 months |
| Disease Control Rate (DCR) | Disease control is deļ¬ned as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 5 weeks). | up to approximately 24 months. |
| Duration of response (DOR) | Duration of response assessed by RECIST 1.1. Duration of response is defined as the time from when the criteria for CR or PR were first met to the occurrence of an objective disease progression (PD) or death. | up to approximately 24 months. |
| Overall survival (OS) | OS is defined as time from first study treatment to death due to any cause. | up to approximately 24 months. |
| Observed maximum plasma concentration (Cmax) of HS-20093 | Cmax of HS-20093 | up to approximately 24 months. |
| Area Under the Plasma Concentration-Time Curve (AUC) of HS-20093 | AUC of HS-20093 | up to approximately 24 months. |
| Percentage of participants with antibodies to HS-20093 in serum | Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points | up to approximately 24 months. |