This is a phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3014 in participants with unresectable locally advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Fujian cancer hospital
Fuzhou, Fujian, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization
Number ofparticipants with adverse events (AEs)
Time frame: 2 years after LPI
Dose limiting toxicity (DLT) of IBI3014 in Phase 1 dose escalation
The occurance of Dose limiting toxicity (DLT) per protocol to establish MTD or RDEs
Time frame: 21 days after LPI
ORR per RECIST v1.1 in Phase 1 dose expansion and Phase 2 dose optimization
The investigator assessed ORR per RECIST v1.1
Time frame: 2 years after LPI
The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization
Number ofparticipants with abnormal laboratorytests results
Time frame: 2 years after LPI
The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization
Number ofparticipants with abnormal physical examination findings
Time frame: 2 years after LPI
The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization
Number ofparticipants with abnormal vital signs
Time frame: 2 years after LPI
Efficacy of IBI3014
DOR, DoR, TTR, PFS as evaluated by investigator per RECIST v1.1 criteria and OS
Time frame: 2 years after LPI
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15 mg/kg D1 IV Q3W
9 mg/kg D1 IV Q3W
3 mg/kg D1 IV Q3W
20 mg/kg D1 IV Q3W
18 mg/kg D1 IV Q3W
PK profile of IBI3014
area under the curve (AUC)
Time frame: 2 years after LPI
Incidence and characterization of anti-IBI3014 antibodies
Rate of ADA and Nab
Time frame: 2 years after LPI
PK profile of IBI3014
area under the Cmax
Time frame: 2 years after LPI
PK profile of IBI3014
area under the Tmax
Time frame: 2 years after LPI
PK profile of IBI3014
area under the Clearance
Time frame: 2 years after LPI
PK profile of IBI3014
area under the t1/2 and others
Time frame: 2 years after LPI