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This is an interventional study to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CM518D1 in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I dose escalation | Experimental |
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| Phase I dose expansion | Experimental |
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| Phase II | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM518D1 | Biological | CM518D1 will be administered intravenously once every 3 weeks (Q3W) in 6 predetermined dose levels. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT)-Phase I dose escalation | DLT is defined as a toxicity occurring during the DLT observation period. | First cycle (21 days) |
| Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose escalation | An adverse event is defined as any unfavorable medical event that occurs in a subject after receiving the investigational drug, which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria. | Through study completion, an average of 2 years. |
| Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose expansion | An adverse event is defined as any unfavorable medical event that occurs in a subject after receiving the investigational drug, which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria. | Through study completion, an average of 2 years.] |
| Preliminary efficacy-Phase I dose expansion | Preliminary efficacy includes objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), and progression-free survival (PFS). | Through study completion, an average of 2 years.] |
| Objective response rate (ORR)-Phase II | ORR is defined as the proportions of subjects with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to Response Evaluation Criteria in Solid Tumors( RECIST) v1.1. | Through study completion, an average of 2 years.] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | 028-88610620 | qianjia@keymedbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Ruihua Xu | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center (SYSUCC) | Recruiting | Guangzhou | Guangdong | China |
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| CM518D1 | Biological | CM518D1 will be administered intravenously once every 3 weeks (Q3W) in one or more potential recommended phase 2 dose(RP2D). |
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| CM518D1 | Biological | CM518D1 will be administered intravenously once every 3 weeks (Q3W) in different types of solid tumor cohorts. |
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