Evaluating a new treatment for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I clinical trial aims to assess the safety and tolerability of the investigational drug AZD2284, along with AZD2287 and AZD2275, in patients with metastatic castration-resistant prostate cancer. The study is divided into two parts: Part A focuses on determining the optimal dosing regimen and imaging the expression of specific proteins, while Part B involves dose escalation to evaluate the therapeutic efficacy of AZD2284. Participants will undergo various imaging techniques and receive escalating doses of the treatment based on findings from Part A.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* eria:
* • 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 Investigational Medicinal Product (IMP). Participants may have non-measurable lesions including bone only metastases.
* • Adequate organ function
* • Part A only: Metastatic prostate cancer considered to be stable or progressing metastatic castration resistant prostate cancer (mCRPC).
* • Part B only: Progressing mCRPC defined as meeting at least one of following documented criteria -
* a)Serum/plasma PSA progression
* b)Soft-tissue progression
* c)Progression of bone disease
* • Part B Dose Escalation: Previously treated with at least 2 prior lines of systemic anti-cancer therapy for mCRPC. Prior lines must include:
* a)At least 1 androgen receptor pathway inhibitor (ARPI)
* b)A poly (adp-ribose) polymerase (PARP) inhibitor for participants with known BRCA mutation
* c)A checkpoint inhibitor for participants with known microsatellite instability-high (MSI-H), deficient mismatch pair (dMMR), or tumor mutational burden (TMB) ≥ 10 mut/Mb
* • Part B Dose Expansion: Previously treated with at least 1 prior line of systemic anti-cancer therapy for mCRPC. Prior lines must include:
* (a)At least 1 ARPI
* (b)A PARP inhibitor for participants with known BRCA mutation per local practice, unless ineligible per Investigator decision.
* (c)A checkpoint inhibitor for participants with known MSI-H, dMMR, or TMB ≥ 10 mut/Mb.
* (d)No previous cytotoxic chemotherapy for CRPC. Taxanes for metastatic hormone sensitive prostate cancer (mHSPC) is acceptable if the last cycle Day 1 was \> 12 months before first study treatment.
* (e)Previous treatment with prostate specific membrane antigen radioligand therapy (PSMA-RLT) or Radium-223 is allowed but not required. Participants who have had prior radiation therapy, including therapeutic radiopharmaceuticals, external bean radiation therapy (EBRT), and/or brachytherapy are eligible, subject to satisfying all other inclusion/exclusion criteria. Therapeutic radiopharmaceuticals will be considered a prior line of systemic therapy.
* Main

Exclusion Criteria:

* • Treatment with any radiopharmaceutical within 6 weeks of the first dose of Investigational Medicinal Product (IMP).
* • Radiation therapy (RT) or external beam radiation therapy (EBRT) 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
* • Diffuse and intense osseous radiotracer uptake on bone scintigraphy or PSMA imaging characteristic of a superscan.
* • Chronic corticosteroid use greater than 10 mg prednisone equivalent daily.

Where it's running

• Research Site
  Miami, Florida, United States Recruiting
• Research Site
  Tampa, Florida, United States Recruiting
• Research Site
  Chicago, Illinois, United States Recruiting
• Research Site
  Boston, Massachusetts, United States Recruiting
• Research Site
  Omaha, Nebraska, United States Recruiting
• Research Site
  East Melbourne, Australia Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.