Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorAcerand Therapeutics (Hong Kong) Limited
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 groupSponsors and collaborators
Source ClinicalTrials.gov