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This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ia: IBI939 in combination with Sintilimab | Experimental | IBI939 10mg/kg combination with Sintilimab |
|
| Phase Ia:IBI939 in combination with Sintilimab | Experimental | IBI939 20mg/kg combination with Sintilimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI939 | Biological | IBI939 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 3 months | |
| Recommended Phase II Dose(RP2D) | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | Proportion of subjects with complete response (CR) or partial response (PR). | 6 months |
| Disease Control Rate(DCR) | Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Cheng | Jilin Province Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jilin Province Cancer Hospital | Jilin City | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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| Sintilimab | Biological | Sintilimab injection |
|
| 6 months |
| Time to Objective Response (TTR) | Time from randomization to first objective tumor response (CR or PR). | 6 months |
| Duration of Response (DoR) | The time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death. | 6 months |
| Progression-free survival(PFS) | The time from randomization to the first occurrence of objective disease progression or death | 6 months |
| Area under the plasma concentration-time curve (AUC) | 24 hours |
| Maximum concentration (Cmax) | 24 hours |
| Trough concentration (Cmin) | 24 hours |
| Clearance (CL) | 24 hours |
| Volume of distribution (V) | 24 hours |
| Half-life (t1/2) | 24 hours |