GVV858: A New Approach to Castration-Resistant Prostate Cancer Phase 1/2 Trial

GVV858 is a CDK2 inhibitordesigned to block this escape route. Instead of adding another hormone therapy when resistance develops, it targets the cell cycle machinery that CCNE1-amplified tumors depend on. The drug works on the molecular brakes that control when cells divide, rather than trying to manipulate hormone levels further.

CCNE1 amplification allows cancer cells to progress through the cell cycle independently of testosterone signals. While your ADT is working to suppress hormones, CCNE1-amplified cancer cells can still divide using an alternative pathway involving a protein called CDK2. This creates a situation where the cancer becomes resistant not because hormone suppression failed, but because the cancer found a different way to survive altogether.

In mCRPC, CCNE1 amplification appears in a subset of patients and correlates with more aggressive disease and faster progression. This makes it a meaningful clinical target. Preclinical studies show that cancer cells with CCNE1 amplification become dependent on CDK2, suggesting they might be particularly vulnerable to CDK2 inhibition.

Clinical trial.