Enzomenib Enters Phase 2 Trial for Metastatic Prostate Cancer

A new Phase 2 clinical trial will investigate enzomenib (DSP-5336), an experimental oral drug that targets a molecular mechanism different from conventional hormone therapies, in patients with metastatic castration-resistant prostate cancer (mCRPC).

Enzomenib belongs to a class of drugs known as menin inhibitors. Menin is a protein involved in regulating gene activity through interactions with other proteins, including KMT2A. Disrupting these interactions can interfere with molecular programs that support the growth of certain cancers.

The drug has already attracted attention in leukemia research, where menin-dependent signaling plays an important role in specific genetic subtypes. In October 2026, enzomenib received FDA Breakthrough Therapy designation for relapsed or refractory acute leukemia with KMT2A rearrangements.

Its investigation in prostate cancer represents a different application of the same molecular strategy.

Unlike androgen receptor inhibitors, which interfere with the hormonal signals driving prostate cancer, menin inhibitors act on mechanisms involved in gene regulation. Researchers now want to determine whether this approach can produce meaningful antitumor activity in advanced prostate cancer.

Participants will continue androgen deprivation therapy while receiving oral enzomenib twice daily in 28-day treatment cycles.

An interesting feature of the trial is its primary endpoint: metabolic response measured through FDG-PET imaging. Rather than relying exclusively on conventional tumor measurements or PSA changes, researchers will investigate whether treatment reduces metabolic activity within cancer lesions.

The study will also use PSMA-PET imaging, allowing investigators to examine treatment effects in the context of different imaging characteristics of metastatic disease.

Clinical trial