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This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ia Dose-Escalation Stage:IBI939 | Experimental | Participants will be treated with escalating doses of IBI939 to determine the MTD. |
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| Phase Ia Dose-Escalation Stage:IBI939+ Sintilimab | Experimental | Participants will be treated with escalating doses of IBI939 in combination with a fixed dose of Sintilimab to determine the MTD. |
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| Phase Ib Expansion Stage:IBI939+ Sintilimab | Experimental | Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI939 in combination with Sintilimab in different cancer types. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI939 | Drug | Several dose levels will be evaluated for IBI939 administered as a single agent and in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent IBI939 may receive combination treatment with Sintilimab or IBI939+ Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with AEs and SAEs | To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab [Adverse events (AEs), Serious Adverse Events (SAEs) ] | up to 2 years after enrollment |
| Percentage of Participants with Dose-Limiting Toxicities (DLTs) | To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab. | From Baseline to the end of Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: AUC | The area under the curve (AUC) of serum concentration of the drug after the administration. | up to 2 years after enrollment |
| Pharmacokinetics: Cmax | Maximum concentration (Cmax) of the drug after administration |
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Inclusion Criteria:
Eligibility Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital & Institute | Beijing | China |
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| IBI939+ Sintilimab | Drug | IBI939: Several dose levels will be evaluated for IBI939 in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit. |
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| IBI939+ Sintilimab | Drug | IBI939: IBI939 in combination with Sintilimab will be given with RP2D. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit. |
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| up to 2 years after enrollment |
| Immunogenicity: Percentage of ADA positive subjects | Immunogenicity: Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI939. | up to 2 years after enrollment |
| Preliminary anti-tumor activity (Objective Response Rate) | Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors. | up to 2 years after enrollment |