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This is a phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22~180 subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in specified types of solid tumor. Approximately 182 evaluable subjects will be enrolled for phase 2
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI129 | Experimental | IBI129 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI129 | Drug | Subjects will receive IBI129 on Day 1 of a 21-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and PK data), until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first. |
| 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 IBI129 | Number of subjects with dose-limiting toxicities (DLTs) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration (Cmax) of IBI129 | Plasma concentration of IBI129 for single and multiple doses. | 12 months |
| Area under the curve (AUC) of IBI129 | AUC of IBI129 for single and multiple doses. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia | ||
| St George private Hospital |
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|
| 12 months |
| Time to maximum concentration (Tmax) of IBI129 | Tmax of IBI129 for single and multiple doses. | 12 months |
| Clearance (CL) of IBI129 | Clearance of IBI129 from the plasma | 12 months |
| Volume of distribution (V) of IBI129 | Apparent volume of distribution of IBI129. | 12 months |
| Half-life (T1/2) of IBI129 | T1/2 of IBI129 for single and multiple doses. | 12 months |
| Immunogenicity of IBI129 | Incidence of anti-drug (IBI129) antibody | 12 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 |
| Kogarah |
| New South Wales |
| 2217 |
| Australia |
| Wollongong Hospital | Wollongong | New South Wales | 2500 | Australia |
| Hubei Cancer Hospital | Wuhan | Hubei | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| Tianjin Medical university cancer institute & Hospital | Tianjin | Tianjin Municipality | 300000 | China |