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New treatment option for Metastatic Prostate Cancer
Official title Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT07181161
What this study is testing
What is AZD0516?
AZD0516 is an investigational medicine, given as an infusion into a vein, 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
- The main purpose of this study is to assess the safety and tolerability of AZD0516 as monotherapy and/or in combination with other anti-cancer agents for treatment of metastatic prostate cancer.
- 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 130, men only
You may be able to join if
- Main
- Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the prostate. Focal high grade neuroendocrine features are...
- Measurable PSA ≥ 1 μg/L (≥ 1 ng/mL).
- Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) within ≤ 28 days before treatment allocation. Ongoing...
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
You likely can't join if
- Cancer related spinal cord compression, or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a...
- History of leptomeningeal carcinomatosis.
- Unresolved toxicities of Grade ≥ 2 (National Cancer Institute Common Terminology Criteria for Adverse Events v5.0) from prior therapy (excluding...
- Uncontrolled intercurrent illness within the last 12 months.
- Cardiovascular disorder (History of arrhythmia, uncontrolled hypertension, symptomatic hypotension, history of brain perfusion problems, symptomatic...
- History of malignancy
See the full eligibility criteria
- Main
- Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the prostate. Focal high grade neuroendocrine features are permitted.
- Measurable PSA ≥ 1 μg/L (≥ 1 ng/mL).
- Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) within ≤ 28 days before treatment allocation. Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone...
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
- Adequate organ and marrow function in the absence of blood transfusion or growth factor support (within 21 days prior to the scheduled first dose of study intervention).
- Provision of baseline archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumour sample is mandatory.
- Documented current evidence of metastatic prostate cancer
- Life expectancy of at least 12 weeks in the opinion of the investigator
- Documented mCRPC progression at screening as assessed by the investigator with at least one of the following criteria:
- PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the screening visit should be ≥ 1 μg/L (1 ng/mL).
- Radiographic disease progression in soft tissue based on response evaluation criteria in solid tumors (RECIST) v1.1 criteria with or without PSA progression as per prostate cancer working group 3 (PCWG3).
- Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on a bone scan as per PCWG3 with or without PSA progression. Main
- Cancer related spinal cord compression, or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks...
- History of leptomeningeal carcinomatosis.
- Unresolved toxicities of Grade ≥ 2 (National Cancer Institute Common Terminology Criteria for Adverse Events v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with...
- Uncontrolled intercurrent illness within the last 12 months.
- Cardiovascular disorder (History of arrhythmia, uncontrolled hypertension, symptomatic hypotension, history of brain perfusion problems, symptomatic heart failure, prior or current cardiomyopathy, severe valvular heart...
- History of malignancy
- History of non-infectious interstitial lung disease (ILD)/pneumonitis
- Active infection exclusions, including tuberculosis and infections with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
- Any known predisposition to bleeding
- Clinically severe pulmonary compromise
- Participants with Myelodysplastic syndrome (MDS)/Acute Myeloid Leukemia (AML) or with features suggestive of MDS/AML.
- Previous treatment with a STEAP2 targeting modality, chemotherapeutic agent that inhibits topoisomerase activity or metabolic enzymes.
The study team makes the final eligibility decision.
Where it's taking place
- Fayetteville, Arkansas, United States
- Los Angeles, California, United States
- Towson, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Buffalo, New York, United States
- New York, New York, United States
- Providence, Rhode Island, United States
- Myrtle Beach, South Carolina, United States
- Houston, Texas, United States
- Barretos, Brazil
- Porto Alegre, Brazil
- São Paulo, Brazil
- Changsha, China
- Chengdu, China
- Wuhan, China
- Lyon, France
- Montpellier, France
- Saint-Herblain, France
+ 23 more site(s).
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 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fayetteville, Arkansas, United States; Los Angeles, California, United States; Towson, Maryland, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; Detroit, Michigan, United States and 37 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.