The Phase Ia study was designed to evaluate the tolerability, safety, PK, PD, immunogenicity and primary resistance of single therapy tumor activity in subjects with advanced or metastatic solid tumors who have failed standard treatment. Phase Ib study was designed to evaluate the safety and initial efficacy of IBI322 in monotherapy or combination therapy in subjects with advanced or metastatic solid tumors. Investigators and sponsors determine the recommended dose of IBI322 for phase Ib based on PK, PD, safety and efficacy data obtained during phase Ia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Recombinant anti-human CD47/PD-L1 bispecific antibody injection
Shandong Province Cancer Hospital
Jinan, Shandong, China
Number of DLT
Time frame: 21 Days
Number of treatment related AEs
Time frame: up to 90 days post last dose
Number of patients with response
Time frame: Last patient enrolled+24 months
Biomarker evaluation
Time frame: from first dose until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 24 months.
positive rate of ADA&NAB
Time frame: from first dose until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 24 months.
Area under the plsma concentration versus time curve(AUC)
Time frame: Up to 90 days post last dose
Peak Plasma concentration(Cmax)
Time frame: Up to 90 days post last dose
Clearance rate(CL)
Time frame: Up to 90 days post last dose
the distribution volumn (Vd)
Time frame: Up to 90 days post last dose
half-life period(t1/2)
Time frame: Up to 90 days post last dose
Percentage of receptor occupancy
Time frame: Up to 90 days post last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hemoglobin level
Time frame: Up to 90 days post last dose
Reticulocyte count (RET)
Time frame: Up to 90 days post last dose
platelet count (PLT)
Time frame: Up to 90 days post last dose