The main purpose of this study is to evaluate the safety and tolerability of IBI3009 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) of IBI3009.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
190
Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3009)
Westmead Hospital
Westmead, New South Wales, Australia
RECRUITINGWollongong Hospital
Wollongong, New South Wales, Australia
NOT_YET_RECRUITINGNumbers of subjects with adverse events
defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Time frame: Up to 3 years
Number of subjects with clinically significant changes in physical examination results
Clinically significant abnormal physical examination findings reported by the investigator.
Time frame: Up to 3 years
Number of subjects with clinically significant changes in electrocardiogram
Clinically significant abnormal electrocardiogram findings reported by the investigator.
Time frame: Up to 3 years
Number of subjects with clinically significant changes in vital signs
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Time frame: Up to 3 years
Dose limiting toxicities (DLTs)
Dose limiting toxicities (DLTs) to establish MTD and/or RDE.
Time frame: Up to 28 days
area under the curve (AUC)
area under the curve (AUC) of single and multiple doses of IBI3009
Time frame: Up to 3 years
maximum concentration (Cmax)
maximum concentration (Cmax) of single and multiple doses of IBI3009
Time frame: Up to 3 years
time to maximum concentration (Tmax)
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Austin Hospital
Heidelberg, Victoria, Australia
RECRUITINGThe First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGCancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan, Shandong, China
NOT_YET_RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGtime to maximum concentration (Tmax) of single and multiple doses of IBI3009
Time frame: Up to 3 years
clearance (CL)
clearance (CL) of single and multiple doses of IBI3009
Time frame: Up to 3 years
apparent volume of distribution (V)
apparent volume of distribution (V) of single and multiple doses of IBI3009
Time frame: Up to 3 years
half-life (t1/2)
half-life (t1/2) of IBI3009 to the last administration of IBI3009
Time frame: Up to 3 years
anti-drug antibody (ADA)
Incidence and characterization of anti-drug antibody (ADA).
Time frame: Up to 3 years
objective response rate (ORR)
objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
Time frame: Up to 3 years
duration of response (DoR)
duration of response (DoR) as evaluated per the RECIST v1.1 criteria.
Time frame: Up to 3 years
time to response (TTR)
time to response (TTR) as evaluated per the RECIST v1.1 criteria.
Time frame: Up to 3 years
progression free survival (PFS)
as evaluated per the RECIST v1.1 criteria.
Time frame: Up to 3 years
overall survival (OS)
OS is defined as the time from the date of first dose of study drug until the date of death from any cause.
Time frame: Through out the study (an average of 3 years)