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New treatment option for Prostate Cancer (Adenocarcinoma)
Official title Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT06801236
What this study is testing
What is ACE-232 tablets?
ACE-232 tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate cancer (adenocarcinoma).
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 is an open label, phase I, multi-center study aiming to assess the safety and tolerability in patients with metastatic castration resistant prostate cancer (mCRPC).
- Phase 1: an early, usually small safety study
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
- Provide written informed consent
- Metastatic Castration-resistant Prostate Cancer with ongoing androgen - deprivation therapy (ADT) or have bilateral orchiectomy
- Difficult to treat or intolerant to standard treatment (post at least 1 line of NHA and taxane-based chemo in mHSPC or mCRPC), suitable for...
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has a life expectancy of at least 6 months
You likely can't join if
- Receiving any anti-cancer drugs or other treatment, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined...
- Concomitant use of medications or herbal supplements known to be moderate to strong CYP3A4 inhibitors/inducers, or P-gp inhibitors, known to prolong...
- Any previous treatment-related toxicities have not recovered.
- Spinal cord compression or known brain metastases or leptomeningeal carcinomatosis.
- Severe cardiovascular disorders.
- Known gastrointestinal (GI) disorder or GI procedure
See the full eligibility criteria
- Provide written informed consent
- Metastatic Castration-resistant Prostate Cancer with ongoing androgen - deprivation therapy (ADT) or have bilateral orchiectomy
- Difficult to treat or intolerant to standard treatment (post at least 1 line of NHA and taxane-based chemo in mHSPC or mCRPC), suitable for investigational treatment;
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has a life expectancy of at least 6 months
- Adequate organ function and bone marrow function
- Receiving any anti-cancer drugs or other treatment, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period;
- Concomitant use of medications or herbal supplements known to be moderate to strong CYP3A4 inhibitors/inducers, or P-gp inhibitors, known to prolong the QT interval.
- Any previous treatment-related toxicities have not recovered.
- Spinal cord compression or known brain metastases or leptomeningeal carcinomatosis.
- Severe cardiovascular disorders.
- Known gastrointestinal (GI) disorder or GI procedure
- History of gastric and duodenal perforation.
- History of pituitary dysfunction.
- Poorly controlled diabetes mellitus.
- Active or uncontrolled autoimmune disease
- Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis.
- Other malignancies requiring treatment within 3 years prior to the first dose of study drug
- Known allergy or hypersensitivity to any of the excipients of ACE-232.
- Has other medical conditions that at the discretion of the investigator interfere with safety or how well it works evaluation, or treatment compliance.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Tampa, Florida, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Omaha, Nebraska, United States
- Myrtle Beach, South Carolina, United States
- Seattle, Washington, United States
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 La Jolla, California, United States; Tampa, Florida, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Minneapolis, Minnesota, United States; Omaha, Nebraska, United States and 2 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.