In this phase Ib/II study, participants with metastatic castration-resistant prostate cancer (mCRPC) who failed prior novel hormone therapy will be treated with XNW5004 in combination with enzalutamide.
Patients must have the ability to understand and sign an approved informed consent form (ICF).
Age at the time of consent ≥ 18 years;
Life expectancy of ≥ 3 months;
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
Previous anti-tumor therapy meet the following conditions： Ib and IIb: previously received any next generation androgen receptor antagonists (such as enzalutamide, apalutamide, proxalutamide and rezvilutamide, etc.) ； IIa: previously received with enzalutamide or more than 1 novel hormone therapy;
Prior chemotherapy for castration resistant disease (including but not limited to ADCs);
Prior exposure to EZH2 inhibitor(s) (including but not limited to tazemetostat and EZH1/2 inhibitors);
Subjects who received anti-tumor therapies including chemotherapy, immunotherapy, radical radiotherapy, major surgery, targeting therapy and other anti-tumor therapies within 4 weeks or 5 half-lives of the drug (whichever is shorter) before the first dose; or received palliative radiotherapy within 2 weeks before the first dose;
Sequential
XNW5004
DrugOral continuous
enzalutamide
Drugenzalutamide 160 mg (four 40 mg capsules) orally once daily
Ph Ib/IIa: Overall safety profile including adverse events
Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version \[5.0\])
Ph Ib/IIa: Recommended phase 2 doses (RP2D) of XNW5004 in combination with enzalutamide
RP2D of XNW5004 as administered orally twice daily (BID), continuously in 28-day cycles, in combination with enzalutamide in subjects with mCRPC by safety data, pharmacokinetic data, pharmacodynamic data and efficacy data
Preliminary efficacy determination as evaluated by disease specific response criteria
Radiographic Progression-free survival（rPFS）was defined as the time from the date of first administration of the study drug to the date of radiographic progression base on the investigator assessment per PCWG3 criteria or death due to any cause (whichever comes first) in Phase IIa/IIb.
Ph Ib/IIa: Pharmacokinetic Parameters
The area under the plasma concentration-time curve (AUC)
Ph Ib/IIa: Pharmacokinetic Parameters
Maximum plasma concentration (Cmax)
Ph Ib/IIa: Pharmacokinetic Parameters
Elimination half-life (t1/2)
Ph Ib/IIa: Pharmacokinetic Parameters
Time to maximum plasma concentration (Tmax)
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