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New treatment option for Metastatic Prostate Cancer
Official title First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer
ClinicalTrials.gov ID: NCT07529717
What this study is testing
What is AZD8359?
AZD8359 is an investigational medicine, being studied as a potential treatment for metastatic 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
- This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD8359. The study is split into different modules which will look at AZD8359 delivered by different methods.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100, men only
You may be able to join if
- Histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer
- Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L)
- PSA value at screening should be ≥ 1ng/mL
- Evidence of disease progression within 6 months prior to screening
- Part A Participants should have received at least 2 prior approved systemic therapies for prostate cancer with at least one androgen receptor pathway...
You likely can't join if
- Any clinically relevant cardiac abnormalities such as QT prolongation or uncontrolled cardiac arrythmias
- All prior treatment-related adverse events must have resolved to Grade ≤ 2
- History of Grade ≥ 3 cytokine release syndrome or Grade ≥ 2 immune effector cell-associated neurotoxicity syndrome with prior therapy
- Active or prior documented autoimmune or inflammatory disorders within the past 3 years
- Prior exposure to any STEAP2 targeted agents or TCEs for prostate cancer
See the full eligibility criteria
- Histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer
- Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L)
- PSA value at screening should be ≥ 1ng/mL
- Evidence of disease progression within 6 months prior to screening
- Part A Participants should have received at least 2 prior approved systemic therapies for prostate cancer with at least one androgen receptor pathway inhibitor and at least one taxane regimen if amenable
- Part B Participants should have received an androgen receptor pathway inhibitor for metastatic hormone sensitive prostate cancer or metastatic castration resistant prostate cancer (mCRPC). No prior taxane treatment for...
- Adequate organ function
- Body weight ≥ 35 kg
- Any clinically relevant cardiac abnormalities such as QT prolongation or uncontrolled cardiac arrythmias
- All prior treatment-related adverse events must have resolved to Grade ≤ 2
- History of Grade ≥ 3 cytokine release syndrome or Grade ≥ 2 immune effector cell-associated neurotoxicity syndrome with prior therapy
- Active or prior documented autoimmune or inflammatory disorders within the past 3 years
- Prior exposure to any STEAP2 targeted agents or TCEs for prostate cancer
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
- East Brunswick, New Jersey, United States
- Hackensack, New Jersey, United States
- Providence, Rhode Island, United States
- Darlinghurst, Australia
- Melbourne, Australia
- Seoul, South Korea
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 to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States; East Brunswick, New Jersey, United States; Hackensack, New Jersey, United States; Providence, Rhode Island, United States; Darlinghurst, Australia; Melbourne, Australia and 1 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.