Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
a study on Prostate Cancer Metastatic Castration-Resistant Prostate Cancer
Summary
- Eligibility
- for males ages 18 years and up (full criteria)
- Location
- at UCSD
- Dates
- study startedstudy ends around
Description
Summary
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).
Official Title
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)
Details
The study consists of two parts, Phase 1A dose escalation and Phase 1B dose optimization. Phase 1A aims to assess the safety, tolerability, pharmacokinetic (PK) profile, and changes in pharmacodynamic (PD) markers in patients treated with ACE-232, and to determine the maximum tolerated dose (MTD), if applicable. In Phase 1B, patients with AR gene alterations will be treated at two different dose levels to establish the recommended Phase 2 dose (RP2D).
Keywords
Prostate Cancer (Adenocarcinoma), mCRPC (Metastatic Castration-resistant Prostate Cancer), ACE-232, castration-resistant prostate cancer, CRPC, Hormone Antagonists, Hormone Substitutes, Antineoplastic Agents, Prostatic Neoplasms, Castration-Resistant, prostate cancer, CYP11A1, Adenocarcinoma, ACE-232 tablets
Eligibility
You can join if…
Open to males ages 18 years and up
- 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
You CAN'T join if...
- 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.
Locations
- University of California San Diego, Moores Cancer Center
accepting new patients
La Jolla 5363943 California 5332921 92093 United States - Fred Hutchinson Cancer Research Center
not yet accepting patients
Seattle 5809844 Washington 5815135 98109 United States - Xcancer (Urology Cancer Center)
accepting new patients
Omaha 5074472 Nebraska 5073708 68130 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Acerand Therapeutics (Hong Kong) Limited
- ID
- NCT06801236
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 67 study participants
- Last Updated