Spots Global Cancer Trial Database for SC10914 Monotherapy for the mCRPC With g/s BRCA Mutation

Study Description

Brief Summary: 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.

Detailed Description: 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）.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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