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This is an open-label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and efficacy of MG2512 injection in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG2512 Injection Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG2512 Injection | Drug | MG2512 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | 3 weeks. | |
| Maximum tolerated dose (MTD) | 3 weeks. | |
| Recommended Phase 2 Dose (RP2D) | From screening period up to study completion, an average of 1 year. | |
| Adverse events (AEs) | From screening period up to study completion, an average of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentration of MG2512 after single and continuous administration | From screening period up to study completion, an average of 1 year. | |
| Time to reach maximum plasma concentration (Tmax) | PK parameters of MG2512 after single and continuous administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongfu Mao | Contact | +86-021-61053363 | rongfu.mao@hengrui.com | |
| Hao Shen | Contact | +86-021-61053363 | hao.shen@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100032 | China |
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| From screening period up to study completion, an average of 1 year. |
| Maximum plasma Concentration (Cmax) | Pharmacokinetics (PK) parameters of MG2512 after single and continuous administration. | From screening period up to study completion, an average of 1 year. |
| Area under the curve from zero to time t (AUC0-t) | Pharmacokinetics (PK) parameters of MG2512 after single and continuous administration. | From screening period up to study completion, an average of 1 year. |
| Drug Resistant Antibody (ADA) to MG2512 | From screening period up to study completion, an average of 1 year. |
| Objective response rate (ORR) | From screening period up to study completion, an average of 1 year. |
| Disease control rate (DCR) | From screening period up to study completion, an average of 1 year. |
| Progression-free survival (PFS) | From screening period up to study completion, an average of 1 year. |
| Overall survival (OS) | From screening period up to study completion, an average of 1 year. |
| Sichuan Cancer Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
|