SHR-4394: Phase 1/2 Trial Explores CDK4/6 Inhibition in Metastatic Prostate Cancer Combinations

A promising Phase 1/2 clinical trial  is investigating SHR-4394, a selective CDK4/6 inhibitor, combined with anti-tumor therapies such as rezvilutamide, HRS-5041, or tazemetostat in men with metastatic prostate cancer.

CDK4/6 inhibitors like SHR-4394 block a key pathway that makes prostate cancer cells grow out of control. This pathway uses proteins called cyclin D, CDK4/6, and RB: the CDKs over-activate RB, freeing up E2F factors that speed up cell division. In advanced prostate cancer that’s resistant to hormone treatments (mCRPC), this pathway helps tumors resist drugs, spread, and change into aggressive forms. Lab studies show SHR-4394 stops growth, puts cells into a dormant state, and works better with other drugs like PARP or AKT inhibitors to kill cancer cells.

As genetic alterations in the CDK4/6 axis are common in aggressive prostate tumors, SHR-4394 could redefine combination strategies, building on successes in other cancers to improve survival in mCRPC.

Clinical trial.