Recruiting NCT06083207
A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IBI3003.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I/II, Multicenter, Open-label, First-in-human Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
Overview
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.
Interventions
- 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.
Primary outcome measures
- Adverse events (AEs) [Time frame: Up to 30 days post last dose]
Secondary outcome measures (1)
- Dose limiting toxicities (DLTs) [Time frame: Up to 28 days post first dose]
Eligibility 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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 10 centers
- Peking Union Medical College Hospital — Beijing
- The first Affiliated Hospital of Guangxi Medical University — Nanning
- Tongji Medical College of HUST Tongji Hospital — Wuhan
- Jiangsu Province Hospital — Nanjing
- The First Affiliated Hospital of Soochow University — Suzhou
- The Affiliated Hospital of Xuzhou Medical University — Xuzhou
- Jiangxi Cancer Hospital — Nanchang
- ZhongShan Hospital FuDan University — Shanghai
- … and 2 more centers
Australia · 3 centers
- Wollongong Private Hospital — Wollongong
- Austin Hospital — Heidelberg
- St Vincent's Hospital — Melbourne
Identifiers
NCT: NCT06083207 · CIBI3003A101