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A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
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.
Official title: A Phase I/II, Multicenter, Open-label, First-in-human Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2024-07-29
Completion Date
2027-10-31
Last Updated
2024-12-13
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (13)
Wollongong Private Hospital
Wollongong, New South Wales, Australia
Austin Hospital
Heidelberg, Victoria, Australia
St Vincent's Hospital
Melbourne, Victoria, Australia
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The first Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Tongji Medical College of HUST Tongji Hospital
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
ZhongShan Hospital FuDan University
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of XI'AN Jiaotong University
Xian, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China