Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorEvopoint Biosciences Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • XNW5004
  • enzalutamide

Treatment groups

307 Participants
are divided into 3 treatment groups

Sponsors and collaborators