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

P1-IMU-935-CRPC

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).

2021-12-09

2023-05-31

2023-05-31

Terminated

Early phase I

18

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

2024-01-17