To evaluate the safety and tolerability of IBI3005 combination therapy in participants with advanced solid tumors; to evaluate the antitumor activity of IBI3005 combination therapy in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
282
Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)
Anti-PD-1 Monoclonal Antibody
Recombinant humanized anti-VEGF monoclonal antibody
SunYat-sen University Cancer Center
Guangzhou, Guangdong, China
Number of subjects with adverse events
defined as any untoward medical occurrence, whether or not thereis 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 treatment emergent adverse events
defined as any untoward medical occurrence, whether or not thereis 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 weeks
Number of subjects with adverse events of special interest
defined as any untoward medical occurrence, whether or not thereis 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 serious adverse events
defined as any untoward medical occurrence, whether or not thereis 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
Dose limiting toxicities (DLTs)
Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
Time frame: Up to 3 weeks
Number of subjects with clinically significant changes in laboratory tests results
Clinically significant abnormal laboratory tests results reported by the investigator.
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.
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Third-generation EGFR-TKI
Third-generation EGFR-TKI
Second-generation platinum-based chemotherapy drugs
Time frame: Up to 3 years
Number of subjects with clinically significant changes in vital signs
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Time frame: Up to 3 years
Objective Response Rate, (ORR)
as evaluated per the RECIST v1.1 criteria.
Time frame: Up to 3 years
duration of response (DCR)
as evaluated per the RECIST v1.1 criteria.
Time frame: Up to 3 years
time to response (TTR)
as evaluated per the RECIST v1.1 criteria.
Time frame: Up to 3 years
duration of response (DoR)
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
overall survival (OS)
Time frame: Up to 3 years
area under the curve (AUC)
area under the curve (AUC) of single and multiple doses of IBI3005
Time frame: Up to 3 years
maximum concentration (Cmax)
maximum concentration (Cmax) of single and multiple doses of IBI3005
Time frame: Up to 3 years
time to maximum concentration (Tmax)
time to maximum concentration (Tmax) of single and multiple doses of IBI3005
Time frame: Up to 3 years
clearance (CL)
clearance (CL) of single and multiple doses of IBI3005
Time frame: Up to 3 years
apparent volume of distribution (V)
apparent volume of distribution (V) of single and multiple doses of IBI3005
Time frame: Up to 3 years
half-life (t1/2)
half-life (t1/2) of IBI3005 to the last administration of IBI3005
Time frame: Up to 3 years
anti-drug antibody (ADA)
Incidence and characterization of anti-drug antibody (ADA).
Time frame: Up to 3 years