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Clinical Trials in Australia / NCT06083207
Recruiting Phase 1/2

A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma

NCT06083207 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1/2
Started
2024-07-29
Last updated
2024-12-13

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

IBI3003 →

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)

Trial sites (13)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT06083207 on ClinicalTrials.gov ↗ ← All trials in Australia