Clinical Trial 23770

• Overview

  Study Title:

  A Phase I, First-in-human, Dose Escalation Study Of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer

  Summary:

  This study is to learn more about the safety, tolerability, and effectiveness of 3 study drugs (AZD2284, AZD2275, and AZD2287). Investigators will also look at how the body takes up, delivers, breaks down and removes the study drug (pharmacokinetics) and how the body is affected by the study drug (pharmacodynamics), anti-tumor activity, and to better understand the studied disease and associated health problems

  Objective:

  Primary Safety: *Evaluate the safety and tolerability of AZD2284, AZD2287, and AZD2275. *Determine the Recommended Phase 2 Dose (RP2D) of AZD2284. Primary Dosimetry: *Assess the effect of pre-dose administration of AZD2275 on the radiation dosimetry of AZD2287 and estimate the radiation dosimetry of AZD2284. Secondary Efficacy: *Assess preliminary anti-tumor activity of AZD2284. Secondary PK: *Determine the PK of AZD2284, AZD2287, and AZD2275. *Assess the effect of pre-dose administration of AZD2275 on the PK of AZD2287 and AZD2284, as applicable. Secondary Immunogenicity: *To assess the immunogenicity of AZD2284, AZD2287, and AZD2275.

• Treatments

  Therapies:

  Radioimmuno-SPECT imaging agent; Radiopharmaceutical; STEAP2 directed monoclonal antibody

  Medications:

  AZD2275 (); AZD2284 (); AZD2287 ()

• Inclusion Criteria

  Inclusion Criteria:
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer.
  • Must have had prior bilateral orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum/plasma testosterone (> At least one metastatic lesion present on baseline Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or bone scan obtained ≤ 28 days prior to the first dose of Investigational Medicinal Product (IMP). Participants may have non-measurable lesions including bone only metastases.
  • Adequate organ function
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Treatment with any radiopharmaceutical within 6 weeks of the first dose of Investigational Medicinal Product (IMP).
  • Radiation therapy (RT) within 28 days prior to the first dose and all RT-related events have not recovered to Grade 1 or greater
  • Administration of any systemic cytotoxic or investigational therapy ≤ 28 days of the first dose of IMP or 5 half-lives, whichever is shorter.
  • All prior treatment-related adverse events must have resolved to Grade ≤ 1.
  • Concurrent severe and/or uncontrolled illness not related to cancer and/or social situation that would limit compliance with study requirements.
  • Known or suspected allergies or contraindications to any of the investigational drugs or any component of the investigational drug formulation.
  • Clinically relevant proteinuria
  • Other exclusions may apply

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.