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This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label: IBI3001 monotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3001 | Drug | The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the study. IBI3001 is proposed to be administered by intravenous infusion (IV) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria | 24 months |
| Number of subjects with clinically significant changes in physical examination results | Clinically significant abnormal physical examination findings reported by the investigator. | 24 months |
| Number of subjects with clinically significant changes in vital signs | Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure | 24 months |
| MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs) | Dose limiting toxicity (DLT) to establish MTD or RP2D | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration (Cmax) of IBI3001 | Plasma concentration of IBI3001 for single and multiple doses. | 24 months |
| Area under the curve (AUC) of IBI3001 | AUC of IBI3001 for single and multiple doses |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sujie Zhang | Contact | 86-13811303576 | sujie.zhang@innoventbio.com | |
| Yue Qu | Contact | 86-18664524992 | yue.qu@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wollongong Public | Recruiting | Wollongong | New South Wales | 2500 | Australia |
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| 24 months |
| Time to maximum concentration (Tmax) of IBI3001 | Tmax of IBI3001 for single and multiple doses. | 24 months |
| Clearance (CL) of IBI3001 | Clearance of IBI3001 from the plasma | 24 months |
| Volume of distribution (V) of IBI3001 | Apparent volume of distribution of IBI3001 | 24 months |
| Half-life (T1/2) of IBI3001 | T1/2 of IBI3001 for single and multiple doses | 24 months |
| Immunogenicity of IBI3001 | Incidence of anti-drug (IBI3001) antibody | 24 months |
| Objective response rate (ORR) | ORR as evaluated per the RECIST v1.1 criteria | 24 months |
| Duration of response (DoR) | DoR as evaluated per the RECIST v1.1 criteria | 24 months |
| Disease control rate (DCR) | DCR as evaluated per the RECIST v1.1 criteria | 24 months |
| Time to response (TTR) | TTR as evaluated per the RECIST v1.1 criteria | 24 months |
| Progression free survival (PFS) | PFS as evaluated per the RECIST v1.1 criteria | 24 months |
| Overall survival (OS) | Overall survival. | 24 months |
| Cancer Research SA | Recruiting | Adelaide | South Australia | 5000 | Australia |
|
| Chinese PLA General Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100853 | China |
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| Shanghai East Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| The First Affiliated Hospital of zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310003 | China |
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