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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
116
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.
Wollongong Private Hospital
Wollongong, New South Wales, Australia
SUSPENDEDAustin Hospital
Heidelberg, Victoria, Australia
Adverse events (AEs)
Number of patients who Experienced related AEs from the first dose until 30 days after the last dose
Time frame: Up to 30 days post last dose
Dose limiting toxicities (DLTs)
To evaluate the safety and tolerability of IBI3003
Time frame: Up to 28 days post first dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St Vincent's Hospital
Melbourne, Victoria, Australia
SUSPENDEDPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe first Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
NOT_YET_RECRUITINGTongji Medical College of HUST Tongji Hospital
Wuhan, Hubei, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
NOT_YET_RECRUITINGThe Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGJiangxi Cancer Hospital
Nanchang, Jiangxi, China
NOT_YET_RECRUITING...and 3 more locations