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This is a first-in-human, non-randomized, open-label, multicenter Phase 1 study of AMT-562 in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | AMT-562 Dose Escalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMT-562 | Drug | Administered AMT-562 for injection intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLTs | Incidence of dose limiting toxicities | up to 24 month |
| AEs | Type, incidence and severity of Adverse Events | up to 24 month |
| SAEs | Type, incidence and severity Serious Adverse Events (SAEs) | up to 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration (Cmax) | up to 24 month |
| Tmax | time to peak drug concentration | up to 24 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minqi Guan | Contact | 86-15895820062 | minqi.guan@multitudetherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macquarie University Hospital | Recruiting | North Ryde | New South Wales | Australia |
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| AUC | Area Under the Curve | up to 24 month |
| t1/2 | terminal half-life of the ADC, total antibody and free payload | up to 24 month |
| ADAs | Specification and quantification of anti-drug antibodies | up to 24 month |
| ORR | Overall response rate assessed by the investigator according to RECIST version 1.1 | up to 24 month |
| DCR | Disease control rate assessed by the investigator according to RECIST version 1.1 | up to 24 month |
| PFS | Progression-free survival assessed by the investigator according to RECIST version 1.1 | up to 24 month |
| TTR | Time to response assessed by the investigator according to RECIST version 1.1 | up to 24 month |
| DOR | Duration of response assessed by the investigator according to RECIST version 1.1 | up to 24 month |
| Cabrini Malvern Hospital | Recruiting | Malvern | Victoria | Australia |
|