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This study is a multicenter, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial, which aims to observe and evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of HRS2398 combined with Adebrelimab injection in patients with advanced solid tumors, determine the RP2D, and preliminarily evaluate the efficacy of HRS2398 combined with Adebrelimab in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS2398 given in combination with adebrelimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS2398 | Drug | HRS2398: Tablets, 40mg/tablet, oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects with dose-limiting toxicity (DLT) | From first dose of study treatment until the end of Cycle 1(up to 28 days) | |
| Determination of Recommended Phase II dose (RP2D) | From first dose of study treatment until the end of Cycle 1(up to 28 days) | |
| Objective Response Rate (ORR) | From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months) | |
| Duration of Response (DoR) | From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Xu | Contact | 0518-82342973 | xin.xu@hengrui.com | |
| Yuting Wang | Contact | 0518-82342973 | yuting.wang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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| Adebrelimab |
| Drug |
Adebrelimab (SHR-1316): injection, 600mg(12mL), intravenous infusion |
|
| Progression free Survival (PFS) | From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months) |
| Overall Survival (OS) | From time of first dose of objective disease progression until the date of death (up to 24 months) |
| Time To Response(TTR) | From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months) |
| Shanghai Chest Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200030 | China |
|