This study is a multicenter, single arm phase I / II clinical study in mCRPC subjects who failed to receive docetaxel chemotherapy, abitolone acetate and / or enzalutamide (including its analogues) for the treatment of BRCA mutations in germ cells and / or somatic cells.
The subjects oral administration sc10914 tablets 400mg on an empty stomach, three times a day, for 28 consecutive days as a treatment cycle, until disease progression (PD) (according to Recist1.1 and the adjusted PCWG3 standard, the subjects met the imaging \[CT / MRI / bone scan\] PD standard) or the toxicity was intolerable. The study is divided into two stages: in the first stage,enrolled 36 patients whose response can be evaluated, if there are at least 7 cases of objective remission (CR or PR), the second stage is allowed, otherwise the study will be stopped; in the second stage, the number of subjects whose response can be evaluated is planned to continue to be enrolled to 70 cases(stage 1 and stage 2).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
S410914 tablet
objective response rate (ORR)
assessed by the independent imaging assessment committee (recist1.1)
Time frame: up to 100 weeks (estimated)
PFS
Time frame: up to 100 weeks (estimated)
Disease control rate (DCR), duration of response (DOR), time to tumor progression (TTP)
evaluated according to recist1.1 and adjusted pcwg3 criteria
Time frame: up to 100 weeks (estimated)
overall survival (OS)
evaluated according to recist1.1 and adjusted pcwg3 criteria
Time frame: up to 100 weeks (estimated)
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