Status:
RECRUITING
A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 Do...
Eligibility Criteria
Inclusion
- Subjects in Parts 1(dose escalation) \& 2 (dose expansion) must satisfy all of the following criteria to be enrolled into the study:
- Age ≥18 years. For Part 1, age ≥18 years and ≤75 years.
- Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria. Multiple myeloma is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma-defining events in protocol
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Life expectancy ≥3 months.
- 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
- Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- 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.
- 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.
- History of primary immunodeficiency.
- 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.
Key Trial Info
Start Date :
July 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06083207
Start Date
July 29 2024
End Date
October 31 2027
Last Update
December 13 2024
Active Locations (13)
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1
Wollongong Private Hospital
Wollongong, New South Wales, Australia, 2500
2
Austin Hospital
Heidelberg, Victoria, Australia, 3084
3
St Vincent's Hospital
Melbourne, Victoria, Australia, 3065
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730