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| Name | Class |
|---|---|
| Fortvita Biologics (USA)Inc. | INDUSTRY |
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The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI3020 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3020 | Drug | Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection |
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| 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, oxygen saturation by pulse oximetry at rest and blood pressure | Up to 3 years |
| Dose limiting toxicities (DLTs) | Dose limiting toxicities (DLTs) to establish MTD and/or RP2D. | Up to 21 days |
| objective response rate (ORR) | objective response rate (ORR) as evaluated per the RECIST v1.1 criteria. | Up to 3 years |
| Number of subjects with clinically significant changes in laboratory parameters | Clinically significant abnormal laboratory parameters findings reported by the investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| area under the curve (AUC) | area under the curve (AUC) of single and multiple doses of IBI3020 | Up to 3 years |
| maximum concentration (Cmax) | maximum concentration (Cmax) of single and multiple doses of IBI3020 |
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Inclusion Criteria:
Participants must satisfy all of the following criteria to be enrolled into the study:
Exclusion Criteria:
Participants who meet any of the following criteria will be disqualified from entering the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serena Dong | Contact | 051269566088 | suhua.dong@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Arizona | Recruiting | Pheonix | Arizona | 85054 | United States |
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| Up to 3 years |
| Up to 3 years |
| time to maximum concentration (Tmax) | time to maximum concentration (Tmax) of single and multiple doses of IBI3020 | Up to 3 years |
| clearance (CL) | clearance (CL) of single and multiple doses of IBI3020 | Up to 3 years |
| apparent volume of distribution (V) | apparent volume of distribution (V) of single and multiple doses of IBI3020 | Up to 3 years |
| half-life (t1/2) | half-life (t1/2) of IBI3020 to the last administration of IBI3020 | 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 |
| disease control rate (DCR) | disease control rate (DCR)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. | From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months |
| Mayo Clinic - Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Mayo Clinic - Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Montefiore Cancer Center | Recruiting | New York | New York | 10461 | United States |
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| NEXT Houston | Recruiting | Houston | Texas | 77054 | United States |
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| NEXT Dallas | Recruiting | Irving | Texas | 75039 | United States |
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| The sixth affiliated hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | China |
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| Shanxi Cancer Hospital | Recruiting | Taiyuan | Shanxi | China |
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