A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
A Phase I/II, Multicenter, Open-label, First-in-human Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
1 other identifier
interventional
116
2 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-myeloma
Started Jul 2024
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedStudy Start
First participant enrolled
July 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
December 13, 2024
December 1, 2024
2.3 years
October 9, 2023
December 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs)
Number of patients who Experienced related AEs from the first dose until 30 days after the last dose
Up to 30 days post last dose
Secondary Outcomes (1)
Dose limiting toxicities (DLTs)
Up to 28 days post first dose
Study Arms (1)
IBI3003
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Wollongong Private Hospital
Wollongong, New South Wales, 2500, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
St Vincent's Hospital
Melbourne, Victoria, 3065, Australia
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
The first Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Tongji Medical College of HUST Tongji Hospital
Wuhan, Hubei, 430030, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
ZhongShan Hospital FuDan University
Shanghai, Shanghai Municipality, 201700, China
The First Affiliated Hospital of XI'AN Jiaotong University
Xian, Shanxi, 710061, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300050, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2023
First Posted
October 13, 2023
Study Start
July 29, 2024
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2027
Last Updated
December 13, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share