RecruitingPhase 1NCT06879041
A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase I, First-in-human, Dose Escalation Study Of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
Sponsor
AstraZeneca
Enrollment
95 participants
Start Date
Mar 10, 2025
Study Type
INTERVENTIONAL
Summary
The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria5
- 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
Exclusion Criteria7
- 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
Interventions
DRUGAZD2287
AZD2287 is administered through intravenous injection.
DRUGAZD2275
AZD2275 is administered through intravenous infusion.
DRUGAZD2284
AZD2284 is administered through intravenous injection.
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT06879041