IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer

Inclusion Criteria:

* Age ≥18 years
* Male patients with histologically or cytologically confirmed adenocarcinoma of the prostate with no evidence of small cell or neuroendocrine features
* Metastatic disease with limited therapeutic options, prior treatment with at least one next-generation hormonal agent (e.g., abiraterone, enzalutamide, apalutamide, darolutamide) and one taxane line of treatment is allowed
* Progressive disease is defined as rising prostate-specific antigen (PSA) levels ≥2ng/mL and/or radiographic progression according to Prostate Cancer Working Group 3 (PCWG3) criteria at screening
* Able and willing to comply with all study requirements for the duration of the study
* Patients must sign an ICF prior to the start of any study-related procedures

Exclusion Criteria:

* Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy) within 28 days prior to starting study treatment
* Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with the study protocol
* Malignancy within the previous 2 years with a ≥30% probability of recurrence within 12 months, with the exception of non-melanoma skin cancer or superficial bladder cancer
* Patients receiving strong inhibitors or inducers of cytochrome P450 (CYP) 3A4
* Chronic use of systemic steroid therapy (\>1 month of \>10 mg prednisone per day or equivalent, except replacement therapy)
* Patients for whom biopsies cannot be taken or are not willing to undergo biopsies
* Positive hepatitis B virus (HBV) surface antigen, hepatitis B core antibody, positive hepatitis C virus (HCV) antibody, and/or HIV-antigen-antibody test at screening