An official website of the United States government
A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
Trial Status: active
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.
Inclusion Criteria
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 Criteria
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06083207.
