Phase 1, Dose-Escalation Study of KTX-2001 (an NSD2 Inhibitor)Alone and in Combination with Darolutamide for MetastaticCastration-Resistant Prostate Cancer

KTX-2001 is effective for the treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC). The study drug KTX-2001 has been tested in animals but not yet in people, and it is experimental, which means it is not approved by the United States Food and Drug Administration (FDA). The study drug KTX-2001 is similar to another drug, KTX-1001, that has been tested in people with multiple myeloma, a blood cancer, except for a small change in its chemical makeup which may improve the features of the drug. Darolutamide is a drug that is FDA approved for people with non-metastatic castration-resistant prostate cancer (nmCRPC) and for people with metastatic hormone sensitive prostate cancer (mHSPC). It is not approved for

Are you Eligible? (Inclusion Criteria)

• Age ≥18 years. 2. Male participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) as defined by The Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria. 3. Metastatic disease documented using bone scan for bone metastases (PCWG3 criteria) or by computed tomography (CT) or magnetic resonance imaging (MRI) for soft-tissue metastases. 4. Participants should have progressed on or after receiving an ARPI (eg, abiraterone, enzalutamide, darolutamide, or apalutamide)