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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immunic AG

Criteria

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 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