A Phase I, First-in-human, Dose Escalation Study Of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
AstraZeneca
Summary
The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.
Description
This is a first-in-human, Phase I, non-randomized, open-label clinical trial designed to evaluate AZD2284, AZD2287, and AZD2275. This trial will consist of 2 Parts: Part A (Imaging): \- Part A (Cold Antibody Exploration): aims to determine the optimal dosing regimen, with or without unconjugated antibody (AZD2275) pre-administration to improve the biodistribution of AZD2287. Part B (Therapeutic): * Part B (Actinium-225 Dose Escalation): aims to assess the safety, tolerability, and efficacy of escalating doses of AZD2284 informed by the optimal dosing regimen identified in Part A. * Part B…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Main Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Histologically confirmed diagnosis of adenocarcinoma of the prostate without strong clinical suspicion of majority neuroendocrine differentiation. * Must have had prior bilateral orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * 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 Investiga…
Interventions
- DrugAZD2287
Participants will receive AZD2287
- DrugAZD2275
Participants will receive AZD2275
- DrugAZD2284
Participants will receive AZD2284
Locations (16)
- Research SitePalo Alto, California
- Research SiteSan Diego, California
- Research SiteMiami, Florida
- Research SiteTampa, Florida
- Research SiteChicago, Illinois
- Research SiteMetairie, Louisiana