Tests IBI3003 in adults with relapsed or refractory multiple myeloma
Tests the new drug IBI3003 in adults whose multiple myeloma has returned or not responded.
Plain-language title generated from the registry record
Registry title: A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
Key facts
- Where
- Heidelberg, Melbourne, and Wollongong, AustraliaSee the 3 sites
- Phase
- Phase 1/2
Where in Australia
- Austin HospitalHeidelberg, AustraliaNo longer taking part
- St Vincent's HospitalMelbourne, AustraliaNo longer taking part
- Wollongong Private HospitalWollongong, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Innovent Biologics (Suzhou) Co. Ltd.
- Trial code
- NCT06083207
- Record updated
- 13 December 2024
- Original description
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.Read full original descriptionShow less
A Phase I/II, Multicenter, Open-label, First-in-human Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
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: 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: 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; 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; 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; Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.