Clinical Trial 23692

• Overview

  Study Title:

  A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients with Metastatic Castration-Resistant Prostate Cancer (CRPC)

  Objective:

  Primary objectives: * To characterize safety and tolerability of ACE-232 in patients with metastatic castration-resistant prostate cancer (mCRPC) * To determine recommended Phase 2 dose (RP2D) and maximum tolerated dose (MTD) (if available) of ACE-232 Secondary Objectives: * To characterize the pharmacokinetic(s) (PK) of ACE-232 after single and repeated administration in patients with mCRPC * To investigate the preliminary efficacy and pharmacodynamic(s) (PD) change during investigational treatment in patients with mCRPC

• Treatments

  Therapies:

  CYP11A1 inhibitor

  Medications:

  ACE-232 ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Provide written informed consent.
  • Metastatic Castration-resistant Prostate Cancer with ongoing androgen - deprivation therapy (ADT) or have bilateral orchiectomy.
  • Difficult to treat or intolerant to standard treatment (post at least 1 line of NHA and taxane-based chemo in mHSPC or mCRPC), suitable for investigational treatment.
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Has a life expectancy of at least 6 months.
  • Adequate organ function and bone marrow function.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Receiving any anti-cancer drugs or other treatment, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period.
  • Concomitant use of medications or herbal supplements known to be moderate to strong CYP3A4 inhibitors/inducers, or P-gp inhibitors, known to prolong the QT interval.
  • Any previous treatment-related toxicities have not recovered.
  • Spinal cord compression or known brain metastases or leptomeningeal carcinomatosis.
  • Severe cardiovascular disorders.
  • Known gastrointestinal (GI) disorder or GI procedure.
  • History of gastric and duodenal perforation.
  • History of pituitary dysfunction.
  • Poorly controlled diabetes mellitus.
  • Active or uncontrolled autoimmune disease.
  • Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis.
  • Other malignancies requiring treatment within 3 years prior to the first dose of study drug.
  • Known allergy or hypersensitivity to any of the excipients of ACE-232.
  • Has other medical conditions that at the discretion of the investigator interfere with safety or efficacy evaluation, or treatment compliance.

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