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This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor therapies in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets | Experimental |
| |
| Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2009 for injection ; Almonertinib Mesilate Tablets | Drug | Phase IB: SHR-A2009 will be administered intravenously,Almonertinib Mesilate Tablets will be administered orally. 2 or 3 dose levels are preset in phase IB. Phase II: 2 dose cohorts will be selected and it's randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) (phase IB) | 21 days after the first dose was administered to each subject. | |
| Objective Response Rate (ORR) (phase II). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: toxin-binding antibody of SHR-A2009 | through study completion, an average of 2 years | |
| PK parameter: total antibody of SHR-A2009 | through study completion, an average of 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Qiu | Contact | 0518-82342973 | fei.qiu@hengrui.com |
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| SHR-A2009 for injection;Adebrelimab Injection | Drug | Phase IB: SHR-A2009 and Adebrelimab will be administered intravenously. 2 dose levels are preset in phase IB. Phase II: RPD2 will be selected to evaluate preliminary efficacy. |
|
| PK parameter: free toxin of SHR-A2009 |
| through study completion, an average of 2 years |
| Plasma concentration of Adebrelimab | through study completion, an average of 2 years |
| Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB) | through study completion, an average of 2 years |
| Duration of response(DoR ) | One year after the last subject was enrolled in the group |
| Progression Free Survival(PFS) | 2 years after the last subject was enrolled in the group |
| Objective response rate | 2 years after the last subject was enrolled in the group |
| overall survival (OS) (phase IB) | 3 years after the last subject was enrolled in the group |
| Incidence of AEs(Phase II (efficacy expansion phase)) | from Day1 to 90 days after last dose |
| Incidence of SAEs(Phase II (efficacy expansion phase)) | from Day1 to 90 days after last dose |