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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Subjects in Parts 1(dose escalation) \& 2 (dose expansion) must satisfy all of the following criteria to be enrolled into the study:
1. Age ≥18 years. For Part 1, age ≥18 years and ≤75 years.
2. 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
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
4. Life expectancy ≥3 months.
5. 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:
1. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
2. 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.
3. 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.
4. History of primary immunodeficiency.
5. 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.
Primary outcome measure(s)
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
Trial sites (13)
Facility
City
Region
Status
Wollongong Private Hospital
Wollongong
New South Wales
Suspended
Austin Hospital
Heidelberg
Victoria
Suspended
St Vincent's Hospital
Melbourne
Victoria
Suspended
Peking Union Medical College Hospital
Beijing
Beijing Municipality
Not Yet Recruiting
The first Affiliated Hospital of Guangxi Medical University
Nanning
Guangxi
Not Yet Recruiting
Tongji Medical College of HUST Tongji Hospital
Wuhan
Hubei
Recruiting
Jiangsu Province Hospital
Nanjing
Jiangsu
Not Yet Recruiting
The First Affiliated Hospital of Soochow University
Suzhou
Jiangsu
Not Yet Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Jiangsu
Recruiting
Jiangxi Cancer Hospital
Nanchang
Jiangxi
Not Yet Recruiting
ZhongShan Hospital FuDan University
Shanghai
Shanghai Municipality
Recruiting
The First Affiliated Hospital of XI'AN Jiaotong University
Xian
Shanxi
Not Yet Recruiting
Tianjin Medical University General Hospital
Tianjin
Tianjin Municipality
Not Yet Recruiting
More Innovent Biologics (Suzhou) Co. Ltd. trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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