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New treatment option for Metastatic Prostate Cancer
Official title Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT07590934
What this study is testing
What is AZD2265 (FPI-2265)?
AZD2265 (FPI-2265) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic prostate cancer.
Also referred to as FPI-2265, 225Ac-PSMA-I&T.
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 purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of multiple anti-cancer agents in participants with 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 99, men only
You may be able to join if
- Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or...
- Minimum life expectancy of 3 months or more.
- Eastern Cooperative Oncology Group (ECOG) performance status of O or 1 at screening, with no deterioration.
- PCWG3 (Prostate Cancer Working Group 3) modified RECIST Version 1.1 evaluable disease.
- Must have received at least one novel androgen receptor pathway inhibitor (ARPI), such as enzalutamide or darolutamide or apalutamide or abiraterone...
You likely can't join if
- Any evidence of non adenocarcinomatous forms of prostate cancer (including small cell, spindle cell, signet cell, neuroendocrine, sarcomatous).
- Known, unresolved urinary tract obstruction.
- Participants with a history of central nervous system metastases.
- Symptomatic malignant spinal cord compression or findings indicative of impending cord compression.
- Participants with a history of leptomeningeal carcinomatosis.
- Previous or concurrent cancer distinct from the cancer under investigation in primary site or histology .
See the full eligibility criteria
- Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or signet cell).
- Minimum life expectancy of 3 months or more.
- Eastern Cooperative Oncology Group (ECOG) performance status of O or 1 at screening, with no deterioration.
- PCWG3 (Prostate Cancer Working Group 3) modified RECIST Version 1.1 evaluable disease.
- Must have received at least one novel androgen receptor pathway inhibitor (ARPI), such as enzalutamide or darolutamide or apalutamide or abiraterone acetate.
- Must have one or more unresectable metastatic lesions.
- Must have had prior orchiectomy and/or ongoing androgen deprivation therapy, and a castrate level of serum testosterone (\<50ng/dL or \<l.7nmol/L).
- Progressive metastatic castration-resistant prostate cancer (mCRPC) following the most recent treatment at time of study entry.
- Adequate organ and marrow function.
- Non sterilised participants who are sexually active with a partner of childbearing potential must use a condom (plus spermicide, if available), must refrain from fathering a child, freezing or donating sperm, and it is...
- Must have received a single line of ARPI, such as enzalutamide, darolutamide, apalutamide or abiraterone acetate.
- PSMA positive mCRPC by computed tomography positron emission tomography, obtained with PSMA ligand defined as at least 1 PSMA positive metastatic lesion with tracer uptake greater than liver, and no PSMA negative...
- Capable of self-administering oral formulations.
- Any evidence of non adenocarcinomatous forms of prostate cancer (including small cell, spindle cell, signet cell, neuroendocrine, sarcomatous).
- Known, unresolved urinary tract obstruction.
- Participants with a history of central nervous system metastases.
- Symptomatic malignant spinal cord compression or findings indicative of impending cord compression.
- Participants with a history of leptomeningeal carcinomatosis.
- Previous or concurrent cancer distinct from the cancer under investigation in primary site or histology .
- Concurrent serious medical conditions.
- Previous history of interstitial lung disease or non-infectious pneumonitis.
- Participants with a history or clinical/laboratory features suggestive of myelodysplastic syndrome or acute myeloid leukaemia.
- Persistent toxicities caused by previous therapy.
- Participants unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with absorption.
- Active infection, including tuberculosis, hepatitis C virus, and hepatitis B virus infection.
- Known hypersensitivity to study intervention or any of their excipients. Exclusion Criteria for Sub study 1:
- History of uncontrolled seizures or requirement for \>2 antiepileptic drugs.
- History of severe brain injury or stroke.
- Skeletal metastases demonstrating a superscan appearance on bone scan.
- Participants have received prior therapy with AZD9574 or more than 1 prior line of any other Poly-ADP-ribose polymerase inhibitor (PARPi)-based regimen (either as a treatment or as maintenance).
The study team makes the final eligibility decision.
Where it's taking place
- Encino, California, United States
- South Pasadena, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Metairie, Louisiana, United States
- Minneapolis, Minnesota, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- North Adelaide, Australia
- Essen, Germany
- Jena, Germany
- Rostock, Germany
- Tübingen, Germany
- Bergamo, Italy
- Meldola, Italy
- Milan, Italy
- Roma, Italy
- Seoul, South Korea
+ 9 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 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Encino, California, United States; South Pasadena, California, United States; Miami, Florida, United States; Tampa, Florida, United States; Metairie, Louisiana, United States; Minneapolis, Minnesota, United States and 23 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.