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This is a multicenter, open-label, phase I dose-escalation and expansion study of IBI3026 in participants with unresectable, locally advanced, or metastatic solid tumors. The study will be conducted in two phases: Phase 1 dose escalation and Phase 2 dose expansion. Safety will be monitored by the Safety Review Committee (SRC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI3026 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3026 | Drug | Recombinant anti-programmed death receptor-1 (PD-1) antibody fused with interleukin-12 (IL-12) bispecific molecule injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | up to 2 years | |
| Serious Adverse Event | up to 2 years | |
| Maximum Tolerated Dose | up to 2 years | |
| DLT(Dose-limiting Toxicity) | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PK concentration: IBI3026 serum concentration | up to 2 years | |
| Incidence and number of patients with ADA | up to 2 years | |
| Incidence and number of patients with NAb |
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inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyun Zuo | Contact | 021-31852088 | Haiyun.zuo@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
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| up to 2 years |
| ORR (Objective Response Rate) | up to 2 years |
| DoR(Duration of Response) | up to 2 years |
| DCR(Disease Control Rate) | up to 2 years |
| TTR(Time to Response) | up to 2 years |
| PFS(Progression-free Survival) | up to 2 years |
| OS(Overall Survival) | up to 2 years |