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โ† Trials
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A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllInnovent Biologics (Suzhou) Co. Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Subjects in Parts 1(dose escalation) \& 2 (dose expansion) must satisfy all of the following criteria to be enrolled into the study: 1. Age โ‰ฅ18 years. For Part 1, age โ‰ฅ18 years and โ‰ค75 years. 2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria. Multiple myeloma is defined as clonal bone marrow plasma cells โ‰ฅ10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma-defining events in protocol 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 4. Life expectancy โ‰ฅ3 months. 5. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol. Exclusion Criteria: 1. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. 2. Have amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or solitary plasmacytoma, or smoldering MM as defined by the International Myeloma Working Group(IMWG) criteria. 3. Spinal cord compression that results in limited self-care occurs within 6 months prior to informed consent, or is expected to occur in the near future. 4. History of primary immunodeficiency. 5. Current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.
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What it tests

  • IBI3003
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Where

13 sites
Wollongong Private Hospital
Wollongong, Australia
Austin Hospital
Heidelberg, Australia
St Vincent's Hospital
Melbourne, Australia
Peking Union Medical College Hospital
Beijing, China
The first Affiliated Hospital of Guangxi Medical University
Nanning, China
Tongji Medical College of HUST Tongji Hospital
Wuhan, China
Jiangsu Province Hospital
Nanjing, China
The First Affiliated Hospital of Soochow University
Suzhou, China

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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