This is a phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22\~180 subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in specified types of solid tumor. Approximately 182 evaluable subjects will be enrolled for phase 2
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Subjects will receive IBI129 on Day 1 of a 21-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and PK data), until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
St George private Hospital
Kogarah, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Hubei Cancer Hospital
Wuhan, Hubei, 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 IBI129
Number of subjects with dose-limiting toxicities (DLTs)
Time frame: 12 months
Plasma concentration (Cmax) of IBI129
Plasma concentration of IBI129 for single and multiple doses.
Time frame: 12 months
Area under the curve (AUC) of IBI129
AUC of IBI129 for single and multiple doses.
Time frame: 12 months
Time to maximum concentration (Tmax) of IBI129
Tmax of IBI129 for single and multiple doses.
Time frame: 12 months
Clearance (CL) of IBI129
Clearance of IBI129 from the plasma
Time frame: 12 months
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The First Hospital of Jilin University
Changchun, Jilin, China
Shandong Cancer Hospital
Jinan, Shandong, China
Tianjin Medical university cancer institute & Hospital
Tianjin, Tianjin Municipality, China
Volume of distribution (V) of IBI129
Apparent volume of distribution of IBI129.
Time frame: 12 months
Half-life (T1/2) of IBI129
T1/2 of IBI129 for single and multiple doses.
Time frame: 12 months
Immunogenicity of IBI129
Incidence of anti-drug (IBI129) antibody
Time frame: 12 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