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This is a phase 1/2 multicenter, open-label, first-in-human study of IBI3003. It includes a phase 1 dose escalation and expansion section to identify maximum tolerated dose(MTD)/recommended Phase 2 Dose(RP2D) of IBI3003, plans to enroll 23~116 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI3003 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3003 | Drug | Subjects will receive IBI3003 on Day 1 in a 28-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and pharmacokinetic(PK) data), until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal of consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Number of patients who Experienced related AEs from the first dose until 30 days after the last dose | Up to 30 days post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicities (DLTs) | To evaluate the safety and tolerability of IBI3003 | Up to 28 days post first dose |
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Inclusion Criteria:
Subjects in Parts 1(dose escalation) & 2 (dose expansion) must satisfy all of the following criteria to be enrolled into the study:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serena Dong | Contact | 0512 69566088 | suhua.dong@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wollongong Private Hospital | Suspended | Wollongong | New South Wales | 2500 | Australia | |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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|
| Austin Hospital |
| Suspended |
| Heidelberg |
| Victoria |
| 3084 |
| Australia |
| St Vincent's Hospital | Suspended | Melbourne | Victoria | 3065 | Australia |
| Peking Union Medical College Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100730 | China |
|
| The first Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | 530021 | China |
|
| Tongji Medical College of HUST Tongji Hospital | Recruiting | Wuhan | Hubei | 430030 | China |
|
| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
|
| The First Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | Jiangsu | 215006 | China |
|
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | 221002 | China |
|
| Jiangxi Cancer Hospital | Not yet recruiting | Nanchang | Jiangxi | 330029 | China |
|
| ZhongShan Hospital FuDan University | Recruiting | Shanghai | Shanghai Municipality | 201700 | China |
|
| The First Affiliated Hospital of XI'AN Jiaotong University | Not yet recruiting | Xian | Shanxi | 710061 | China |
|
| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300050 | China |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |