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This is a multicentre, open-label, first-in-human, phase 1/2 study of IBI133 in subjects with unresectable, locally advanced or metastatic solid tumours. Phase 1 section includes three parts, IBI133 dose escalation part, and IBI133 monotherapy dose expansion part. The objective of phase 1 section is to identify MTD/recommended dose for expansion (RDE) of IBI133 monotherapy . The objective of phase 2 section is to further explore efficacy, safety and tolerability of IBI133 monotherapy at RDE in specified tumour population. The treatment cycle of the study is defined as every 3 weeks (21 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label：IBI133 monotherapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI133 | Biological | IBI133: 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 course of the study. Q3W |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicities (DLTs) | DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD)and /or recommended phase 2 dose (RP2D) | 21 days after the first dose of IBI133 |
| Safety: Adverse events (AEs);treatment emergent adverse event(TEAEs),serious adverse events(SAEs) | Adverse events will be assessed by investigator(s)according to NCI-CTCAE v5.0 | Up to 90 days after the last administration |
| Measure | Description | Time Frame |
|---|---|---|
| maximum concentration (Cmax) | PK parameters maximum concentration(Cmax)of IBI133,total antibody,can will be determined | Up to 2 years |
| area under the curve (AUC) | PK parameters clearance rate of IBI133,total antibody,exate can will be determined |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
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| Up to 2 years |
| clearance rate(CL) | PK parameters clearance rateof IBI133,total antibody,exate can will be determined | Up to 2 years |
| half-life (T1/2) | PK parameters half-life of IBI133,total antibody,exate can will be determined | Up to 2 years |
| anti-drug antibody (ADA) | the incidence and characterization of ADA OF IBI133 will be determined | Up to 2 years |
| Preliminary efficacy including objective response rate (ORR) | ORR is defined as the proportion of subjects with a CR or PR. Number and percentage of subjects with CR or PR will be summarized. | Through study completion,Up to 2 years |
| duration of response (DoR) | DoR is defined as the time from the date first achieved CR or PR until the date of first documents disease progression based on RECIST v1.1 or death | Through study completion,Up to 2 years |
| disease control rate (DCR) | DCR is defined as the proportion of subjects with a CR, PR or SD, and will be analysed in the same fashion as ORR. | Through study completion,Up to 2 years |
| ,time to response (TTR) | TTR is defined as the time from the date of first study drug to the date first achieved CR or PR based on RECIST v1.1. | Through study completion,Up to 2 years |
| progression free survival (PFS) | PFS is defined as the time from the date of first study drug to death or disease progression based on RECIST v1.1, whichever occurs first. | Through study completion,Up to 2 years |