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This is a phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3014 in participants with unresectable locally advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI3014 | Experimental | IBI3014 will be dosed until disease progression, toxicity intolerance, starting of new systemic anti-cancer treatment, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaching the maximum of 24 months, whichever occurs first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3014 | Drug | 12 mg/kg D1 IV Q3W |
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| IBI3014 |
| Measure | Description | Time Frame |
|---|---|---|
| The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization | Number ofparticipants with adverse events (AEs) | 2 years after LPI |
| Dose limiting toxicity (DLT) of IBI3014 in Phase 1 dose escalation | The occurance of Dose limiting toxicity (DLT) per protocol to establish MTD or RDEs | 21 days after LPI |
| ORR per RECIST v1.1 in Phase 1 dose expansion and Phase 2 dose optimization | The investigator assessed ORR per RECIST v1.1 | 2 years after LPI |
| The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization | Number ofparticipants with abnormal laboratorytests results | 2 years after LPI |
| The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization | Number ofparticipants with abnormal physical examination findings | 2 years after LPI |
| The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization | Number ofparticipants with abnormal vital signs | 2 years after LPI |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of IBI3014 | DOR, DoR, TTR, PFS as evaluated by investigator per RECIST v1.1 criteria and OS | 2 years after LPI |
| PK profile of IBI3014 | area under the curve (AUC) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhang | Contact | 15005136320 | wei.zhang02@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian cancer hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
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| Drug |
6 mg/kg D1 IV Q3W |
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| IBI3014 | Drug | 1 mg/kg D1 IV Q3W |
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| IBI3014 | Drug | 15 mg/kg D1 IV Q3W |
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| IBI3014 | Drug | 9 mg/kg D1 IV Q3W |
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| IBI3014 | Drug | 3 mg/kg D1 IV Q3W |
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| IBI3014 | Drug | 20 mg/kg D1 IV Q3W |
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| IBI3014 | Drug | 18 mg/kg D1 IV Q3W |
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| 2 years after LPI |
| Incidence and characterization of anti-IBI3014 antibodies | Rate of ADA and Nab | 2 years after LPI |
| PK profile of IBI3014 | area under the Cmax | 2 years after LPI |
| PK profile of IBI3014 | area under the Tmax | 2 years after LPI |
| PK profile of IBI3014 | area under the Clearance | 2 years after LPI |
| PK profile of IBI3014 | area under the t1/2 and others | 2 years after LPI |
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410000 | China |
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| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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