RECRUITING

A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer

Conditions

Metastatic Castration-Resistant Prostate Cancer Dose Escalation Study Metastatic Prostate Cancer Radiopharmaceutical Radiotheranostics Castration-Resistant Prostate Cancer Radiotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.

Official Title

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

Quick Facts

Study Start:2025-03-10

Study Completion:2029-04-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06879041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 (\< 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 Investigational Medicinal Product (IMP). Participants may have non-measurable lesions including bone only metastases. * Adequate organ function	* 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. * 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

Inclusion Criteria

Exclusion 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 (\< 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 Investigational Medicinal Product (IMP). Participants may have non-measurable lesions including bone only metastases.
* Adequate organ function

* 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.
* 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

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Study Locations (Sites)

Research Site

Miami, Florida, 33165

United States

Research Site

Chicago, Illinois, 60637

United States

Research Site

Boston, Massachusetts, 02215

United States

Research Site

Omaha, Nebraska, 68130

United States

Research Site

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-10

Study Completion Date2029-04-16

Study Record Updates

Study Start Date2025-03-10

Study Completion Date2029-04-16

Terms related to this study

Keywords Provided by Researchers

Dose Escalation Study
Metastatic Prostate Cancer
Radiopharmaceutical
Radiotheranostics
Castration-Resistant Prostate Cancer
Radiotherapy

Additional Relevant MeSH Terms

Metastatic Castration-Resistant Prostate Cancer