This is a phase 1/2 multicenter, open-label, first-in-human study of IBI130. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI130, plan to enroll 20\~182 subjects,and a phase 2 to explore efficacy, safety and tolerability of IBI130 at RP2D in specified types of solid tumor.Approximately 150 evaluable subjects will be enrolled for phase 2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Subjects will receive IBI130 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.
Sunshine Coast University
Birtinya, Queensland, Australia
RECRUITINGAdverse events (AEs)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Time frame: Up to 30 days post last dose
objective response rate (ORR)
ORR is the percentage of complete response(CR) plus partial response assessed(PR) per RECIST v1.1 criteria
Time frame: Time from first dose to best response to treatment, assessed up to 3 years
duration of response(DoR)
For subjects with CR or PR,duration of response(DoR) is the time from the first documented CR or PR to disease progression assessed per RESICT v1.1 criteria or death
Time frame: Duration of response from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression, assessed up to 3 years
overall survival (OS)
Time from the date of the first dose to death of the subject due to any cause
Time frame: Time from first dose to death, assessed up to 3 years
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