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This is a first in human, open-label, single-arm, multicenter dose escalation and expansion Phase 1 study of SHR-A2102 in patients with advanced or metastatic solid tumors. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A2102 and preliminary anti-tumor efficacy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A2102 Does Escalation and Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2102 | Drug | All participants receive SHR-A2102 alone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limited Toxicity (DLT) | 21 Days (first cycle) | |
| Maximum tolerable dose (MTD) | 21 Days (first cycle) | |
| Recommended dose for phase II (RP2D) | Up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-A2102 | 30 days after last dose | |
| Maximum observed plasma concentration (Cmax) of SHR-A2102 | 30 days after last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Zhang | Contact | +0518-81220121 | qi.zhang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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open, multicenter, Single Group
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| Time of maximum observed plasma concentration (Tmax) of SHR-A2102 | 30 days after last dose |
| Immunogenicity Analysis | ADA | 30 days after last dose |
| ORR | Objective Response Rate | 24 months |
| DCR | Disease Control Rate | 24 months |
| DoR | Duration of Response | 24 months |
| PFS | Progression-Free-Survival | 24 months |
| OS | Overall survival | 24 months |