The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS4508 DLT, MTD and RP2D, to evaluate the incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0), to evaluate ORR by researchers based on RECIST v1.1, to evaluate the pharmacokinetic (PK) characteristics of HRS-4508 SHR-1811, Capecitabine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
HRS-4508+ Capecitabine
HRS-4508+ Trastuzumab
HRS-4508+ Trastuzumab+ Pertuzumab
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
HRS4508 DLT
Time frame: 3 weeks
HRS4508 MTD
Time frame: 12 weeks
HRS4508 RP2D
Time frame: 12 weeks
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
Time frame: 2 years
Objective response rate (ORR)
Time frame: 1 year
Blood concentrations of HRS-4508
Time frame: 15 weeks
Blood concentrations of SHR-A1811
Time frame: 9 weeks
Blood concentrations of Capecitabine
Time frame: 2 weeks
Objective response rate (ORR)
Time frame: 1 year
Best overall efficacy (BOR)
Time frame: 1 year
Duration of response (DoR)
Time frame: 1 year
Progression free survival (PFS)
Time frame: 1 year
Disease control rate (DCR)
Time frame: 1 year
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HRS-4508+ Trastuzumab+ Capecitabine
Trastuzumab+ Capecitabine
HRS-4508+A1811
Overall survival (OS)
Time frame: 2 year
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
Time frame: 2 years