This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the study. IBI3001 is proposed to be administered by intravenous infusion (IV)
Wollongong Public
Wollongong, New South Wales, Australia
RECRUITINGCancer Research SA
Adelaide, South Australia, Australia
RECRUITINGChinese PLA General Hospital
Beijing, Beijing Municipality, China
Number of subjects with adverse events
Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria
Time frame: 24 months
Number of subjects with clinically significant changes in physical examination results
Clinically significant abnormal physical examination findings reported by the investigator.
Time frame: 24 months
Number of subjects with clinically significant changes in vital signs
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Time frame: 24 months
MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs)
Dose limiting toxicity (DLT) to establish MTD or RP2D
Time frame: 24 months
Plasma concentration (Cmax) of IBI3001
Plasma concentration of IBI3001 for single and multiple doses.
Time frame: 24 months
Area under the curve (AUC) of IBI3001
AUC of IBI3001 for single and multiple doses
Time frame: 24 months
Time to maximum concentration (Tmax) of IBI3001
Tmax of IBI3001 for single and multiple doses.
Time frame: 24 months
Clearance (CL) of IBI3001
Clearance of IBI3001 from the plasma
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Shanghai East Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of zhejiang University School of Medicine
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGTime frame: 24 months
Volume of distribution (V) of IBI3001
Apparent volume of distribution of IBI3001
Time frame: 24 months
Half-life (T1/2) of IBI3001
T1/2 of IBI3001 for single and multiple doses
Time frame: 24 months
Immunogenicity of IBI3001
Incidence of anti-drug (IBI3001) antibody
Time frame: 24 months
Objective response rate (ORR)
ORR as evaluated per the RECIST v1.1 criteria
Time frame: 24 months
Duration of response (DoR)
DoR as evaluated per the RECIST v1.1 criteria
Time frame: 24 months
Disease control rate (DCR)
DCR as evaluated per the RECIST v1.1 criteria
Time frame: 24 months
Time to response (TTR)
TTR as evaluated per the RECIST v1.1 criteria
Time frame: 24 months
Progression free survival (PFS)
PFS as evaluated per the RECIST v1.1 criteria
Time frame: 24 months
Overall survival (OS)
Overall survival.
Time frame: 24 months