Health Trials

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ACE-232 tablets

Treatment groups

67 Participants
are divided into 1 treatment group

Locations

8
California
University of California San Diego, Moores Cancer Center92093, La Jolla United States
Florida
Moffitt Cancer Center, Tampa33612, Tampa United States
Maryland
University of Maryland, Greenebaum Comprehensive Cancer Center21201, Baltimore United States
Massachusetts
Harvard Medical School-Massachusetts General Hospital02114, Boston United States

Sponsors and collaborators

Acerand Therapeutics (Hong Kong) Limited

Lead sponsor

Source ClinicalTrials.gov