A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IBI3003
|
Drug: IBI3003
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.
|
Outcome Measures
Primary Outcome Measures
- Adverse events (AEs) [Up to 30 days post last dose]
Number of patients who Experienced related AEs from the first dose until 30 days after the last dose
Secondary Outcome Measures
- Dose limiting toxicities (DLTs) [Up to 28 days post first dose]
To evaluate the safety and tolerability of IBI3003
Eligibility Criteria
Criteria
Inclusion Criteria:
- Subjects in Parts 1(dose escalation) & 2 (dose expansion) must satisfy all of the following criteria to be enrolled into the study:
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Age ≥18 years. For Part 1, age ≥18 years and ≤75 years.
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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
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Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
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Life expectancy ≥3 months.
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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:
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Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
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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.
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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.
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History of primary immunodeficiency.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wollongong Private Hospital | Wollongong | New South Wales | Australia | 2500 |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI3003A101