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The main purpose of this study is to evaluate the safety and tolerability of IBI3009 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) of IBI3009.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI3009 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3009 | Drug | Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R & D code: IBI3009) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of subjects with adverse events | defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed | Up to 3 years |
| Number of subjects with clinically significant changes in physical examination results | Clinically significant abnormal physical examination findings reported by the investigator. | Up to 3 years |
| Number of subjects with clinically significant changes in electrocardiogram | Clinically significant abnormal electrocardiogram findings reported by the investigator. | Up to 3 years |
| Number of subjects with clinically significant changes in vital signs | Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure | Up to 3 years |
| Dose limiting toxicities (DLTs) | Dose limiting toxicities (DLTs) to establish MTD and/or RDE. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| area under the curve (AUC) | area under the curve (AUC) of single and multiple doses of IBI3009 | Up to 3 years |
| maximum concentration (Cmax) | maximum concentration (Cmax) of single and multiple doses of IBI3009 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lue Shen | Contact | +86 18507159591 | lue.shen@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Hospital | Recruiting | Westmead | New South Wales | 2145 | Australia |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Up to 3 years |
| time to maximum concentration (Tmax) | time to maximum concentration (Tmax) of single and multiple doses of IBI3009 | Up to 3 years |
| clearance (CL) | clearance (CL) of single and multiple doses of IBI3009 | Up to 3 years |
| apparent volume of distribution (V) | apparent volume of distribution (V) of single and multiple doses of IBI3009 | Up to 3 years |
| half-life (t1/2) | half-life (t1/2) of IBI3009 to the last administration of IBI3009 | Up to 3 years |
| anti-drug antibody (ADA) | Incidence and characterization of anti-drug antibody (ADA). | Up to 3 years |
| objective response rate (ORR) | objective response rate (ORR) as evaluated per the RECIST v1.1 criteria. | Up to 3 years |
| duration of response (DoR) | duration of response (DoR) as evaluated per the RECIST v1.1 criteria. | Up to 3 years |
| time to response (TTR) | time to response (TTR) as evaluated per the RECIST v1.1 criteria. | Up to 3 years |
| progression free survival (PFS) | as evaluated per the RECIST v1.1 criteria. | Up to 3 years |
| overall survival (OS) | OS is defined as the time from the date of first dose of study drug until the date of death from any cause. | Through out the study (an average of 3 years) |
| Wollongong Hospital | Not yet recruiting | Wollongong | New South Wales | 2500 | Australia |
| Austin Hospital | Recruiting | Heidelberg | Victoria | 3084 | Australia |
| The First Affiliated Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | 230022 | China |
| The First Affiliated Hospital of Fujian Medical University | Not yet recruiting | Fuzhou | Fujian | 350005 | China |
| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410000 | China |
| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
| Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital) | Not yet recruiting | Jinan | Shandong | 250117 | China |
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310005 | China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |