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The Phase Ia study was designed to evaluate the tolerability, safety, PK, PD, immunogenicity and primary resistance of single therapy tumor activity in subjects with advanced or metastatic solid tumors who have failed standard treatment. Phase Ib study was designed to evaluate the safety and initial efficacy of IBI322 in monotherapy or combination therapy in subjects with advanced or metastatic solid tumors. Investigators and sponsors determine the recommended dose of IBI322 for phase Ib based on PK, PD, safety and efficacy data obtained during phase Ia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI322 | Experimental | Singal arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological: IBI322 | Drug | Recombinant anti-human CD47/PD-L1 bispecific antibody injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of DLT | 21 Days | |
| Number of treatment related AEs | up to 90 days post last dose | |
| Number of patients with response | Last patient enrolled+24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker evaluation | from first dose until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 24 months. | |
| positive rate of ADA&NAB | from first dose until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 24 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinming Yu, M.D. | No.440, Jiyan Road, Jinang City, Shandong Province, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Province Cancer Hospital | Jinan | Shandong | 250117 | China |
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| Area under the plsma concentration versus time curve(AUC) | Up to 90 days post last dose |
| Peak Plasma concentration(Cmax) | Up to 90 days post last dose |
| Clearance rate(CL) | Up to 90 days post last dose |
| the distribution volumn (Vd) | Up to 90 days post last dose |
| half-life period(t1/2) | Up to 90 days post last dose |
| Percentage of receptor occupancy | Up to 90 days post last dose |
| Hemoglobin level | Up to 90 days post last dose |
| Reticulocyte count (RET) | Up to 90 days post last dose |
| platelet count (PLT) | Up to 90 days post last dose |