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RecruitingPhase 1

Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer

A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests the safety of ACE-232 and how well patients can handle it. It is for people with prostate cancer that has spread and keeps growing despite treatment to lower male hormones.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a written form agreeing to join the study.
  • Have prostate cancer that has spread and resists hormone-lowering treatment. You must still receive this treatment or have had both testicles removed.
  • Have cancer that is hard to treat or be unable to handle standard treatment, after at least one newer hormone treatment and taxane chemotherapy. Be suitable for an experimental treatment.
  • Be fully active or able to do light work, even if heavy activity is limited.
  • Be expected to live at least 6 months.
  • Have organs and bone marrow that work well enough. Bone marrow makes blood cells.

Who can't join

  • Have had cancer drugs, other treatment, major surgery, or radiation too recently under study rules, or still have side effects from past treatment.
  • Use certain medicines or herbs that affect how the body handles drugs or can change the heart's electrical rhythm.
  • Have pressure on the spinal cord, cancer spread to the brain, or cancer in the tissue covering the brain and spinal cord.
  • Have severe heart or blood vessel disease; a digestive system disorder or procedure; or a past hole in the stomach or first part of the small intestine.
  • Have a history of problems with the pituitary, a gland that controls hormones; poorly controlled diabetes; or active or uncontrolled disease in which the immune system attacks the body.
  • Have an active infection, a known history of HIV, or known active hepatitis B, hepatitis C, or tuberculosis.
  • Have another cancer that needed treatment within 3 years before the first study dose.
  • Be allergic to any added ingredient in ACE-232, or have another condition that the study doctor thinks could affect safety, study results, or following treatment instructions.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 Exclusion Criteria: * 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 efficacy evaluation, or treatment compliance.

Study sites (8)

CA

FL

MA

MD

MN

NE

SC

WA