Lack of Efficacy

Dose escalation study to evaluate the safety, tolerability and anti-tumor activity of single agent IMU-935 in patients with progressive, metastatic castration resistant prostate cancer (mCRPC).

This is an open-label, non-randomized Phase 1 dose escalation, followed by dose expansion, study to define the safety, tolerability, biomarker change and anti-tumor activity of IMU-935 in patients with mCRPC. Throughout the study, safety, anti-tumor activity, biomarkers and IMU-935 plasma concentrations will be evaluated at regular intervals as per schedule of assessments. Disease progression will be assessed as per standard medical practice.

The dose escalation and expansion parts of the study will have the same treatment duration with similarly structured treatment cycles.

The study will consist of the following periods:

• Screening Period: Approximately 28 days
• Treatment Phase:

Main treatment over 3 cycles of 28 days each, extended treatment as long as patient benefits

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