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New treatment option for Metastatic Castration-Resistant Prostate Cancer
Official title A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT06879041
What this study is testing
What is AZD2287?
AZD2287 is an investigational medicine, being studied as a potential treatment for metastatic castration-resistant prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Main
- 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...
- At least one metastatic lesion present on baseline Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or bone scan obtained ≤ 28 days prior...
You likely can't join if
- . 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...
- 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.
See the full eligibility criteria
- Main
- 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)...
- 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 -
- Serum/plasma PSA progression
- Soft-tissue progression
- 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:
- At least 1 androgen receptor pathway inhibitor (ARPI)
- A poly (adp-ribose) polymerase (PARP) inhibitor for participants with known BRCA mutation
- 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:
- At least 1 ARPI
- A PARP inhibitor for participants with known BRCA mutation per local practice, unless ineligible per Investigator decision.
- A checkpoint inhibitor for participants with known MSI-H, dMMR, or TMB ≥ 10 mut/Mb.
- 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.
- 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...
- . 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.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- San Diego, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Metairie, Louisiana, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- East Melbourne, Australia
- CapeTown, South Africa
- Durban, South Africa
- Pretoria, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; San Diego, California, United States; Miami, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Metairie, Louisiana, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.