Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer (NCT06801236) | Clinical Trial Compass
RecruitingPhase 1
Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
United States67 participantsStarted 2025-05-12
Plain-language 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).
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
What they're measuring
1
Number of patients experiencing adverse events (AEs)/serious adverse events (SAEs)
Timeframe: From time of information consent to 30 days post last dose, up to approximately 37 months
2
Number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol
Timeframe: From the first dose of ACE-232 on Cycle 1 Day 1 up to and including the planned end of Cycle 1 (at the end of 28 days)
3
Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD)