A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

Inclusion criteria

• Confirmed adenocarcinoma of the prostate.
• PSA levels ≥ 2 ng/mL at screening visit.
• Progressing PSA, defined as two consecutive increases in the most recent PSA measurements taken at least 1 week apart.
• Progressed on Androgen Deprivation Therapy (ADT) and at least one prior potent Androgen Receptor (AR) pathway inhibitor given in castration-sensitive prostate cancer setting or approved for castration-resistant prostate cancer (eg, apalutamide, darolutamide, abiraterone, enzalutamide).
• Ongoing primary ADT with gonadotropin-releasing hormone agonist or antagonist in the absence of bilateral orchiectomy.
• Acceptable physical functioning and laboratory measurements, per the study protocol.
• Discontinued prior therapies within protocol-specified timeframes.
• Commit to use of highly-effective contraception while on study and for 90 days after.
• Willing and able to adhere to the study visit schedule and other protocol defined requirements.

Exclusion criteria

• Predominance of small cell carcinoma of the prostate/neuroendocrine prostate cancer in most recent tumor biopsy.
• Participants with brain metastases that require ongoing treatment with radiation or high-dose steroids.
• Not recovered from side effects of prior surgery or cancer treatments.
• Evidence of active viral, bacterial, or fungal infection requiring treatment with antivirals, antibiotics, or anti-fungal medications.
• Prior treatment with AR degraders and molecules with an AR ligand such as AR Regulated Induced Proximity Targeting Chimera (RIPTAC).
• Blood clots ≤ 4 weeks prior to start of treatment.
• Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study drug. Patients may be eligible if the malignancy is clinically stable or has been treated with curative intent.
• Any evidence of severe or uncontrolled systemic diseases.
• Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.