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This is an open-label, Phase I-II, first-in-human (FIH) study of 9MW2921 in patients with locally advanced or metastatic solid tumors refractory to all standard therapies. The objective of this study is to evaluate the safety, tolerability, PK, immunogenicity and Preliminary Antitumor Activity of 9MW2921.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9MW2921 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW2921 | Drug | All subjects will receive 9MW2921 by intravenous (IV) every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limited Toxicity (DLT) | To determine the dose limiting toxicities (DLTs) of 9MW2921 | 21 Days (first cycle) |
| Adverse Events and Serious Adverse Events | Percentage of patients with adverse events (AEs) and serious adverse events (SAEs) | up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on |
| ORR | Defined as the percentage of subjects who experience a best response of either CR or PR. | up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameters: Cmax | Maximum concentration(Cmax) | 1 years |
| PK Parameters: AUC | The area under the curve (AUC) | 1 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhang Jian, Professor | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Centel | Shanghai | 201210 | China |
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| PK Parameters: t1/2 | The half life(t1/2) | 1 years |
| Incidence of ADAs Against 9MW2921 | The incidence of ADAs against 9MW2921 during the study will be summarized | up to 2 years |
| Progression free survival(PFS) according to RECIST 1.1 | Time from the date of first infusion to the earliest date of documented disease progression per radiological evidence or death from any cause | up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on |
| Duration of Response (DoR) according to RECIST 1.1 | Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause. DOR is only defined for subjects who have best overall response of CR or PR. | up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on |
| Disease Control Rate (DCR) according to RECIST 1.1 | Defined as the percentage of subjects who experience a best response of CR, PR or stable disease (SD). | up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on |