The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
285
Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection
Mayo Clinic - Arizona
Pheonix, Arizona, United States
RECRUITINGMayo Clinic - Florida
Jacksonville, Florida, United States
RECRUITINGMayo Clinic - Rochester
Rochester, Minnesota, United States
Numbers 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, oxygen saturation by pulse oximetry at rest and blood pressure
Time frame: Up to 3 years
Dose limiting toxicities (DLTs)
Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
Time frame: Up to 21 days
objective response rate (ORR)
objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
Time frame: Up to 3 years
Number of subjects with clinically significant changes in laboratory parameters
Clinically significant abnormal laboratory parameters findings reported by the investigator.
Time frame: Up to 3 years
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Montefiore Cancer Center
New York, New York, United States
RECRUITINGNEXT Houston
Houston, Texas, United States
RECRUITINGNEXT Dallas
Irving, Texas, United States
RECRUITINGThe sixth affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGShandong Cancer Hospital
Jinan, Shandong, China
RECRUITINGShanxi Cancer Hospital
Taiyuan, Shanxi, China
RECRUITINGarea under the curve (AUC)
area under the curve (AUC) of single and multiple doses of IBI3020
Time frame: Up to 3 years
maximum concentration (Cmax)
maximum concentration (Cmax) of single and multiple doses of IBI3020
Time frame: Up to 3 years
time to maximum concentration (Tmax)
time to maximum concentration (Tmax) of single and multiple doses of IBI3020
Time frame: Up to 3 years
clearance (CL)
clearance (CL) of single and multiple doses of IBI3020
Time frame: Up to 3 years
apparent volume of distribution (V)
apparent volume of distribution (V) of single and multiple doses of IBI3020
Time frame: Up to 3 years
half-life (t1/2)
half-life (t1/2) of IBI3020 to the last administration of IBI3020
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
disease control rate (DCR)
disease control rate (DCR)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: From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months