Clinical trial · Interventional
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)
NCT06801236CI-TRIAL-00120438recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| mCRPC (Metastatic Castration-resistant Prostate Cancer) | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Prostate Cancer (Adenocarcinoma) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACE-232 tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ACE-232
- description
- Administered once daily (QD) continuously at the assigned dose level in accordance with the standard 3+3 dose-escalation scheme
- interventionNames
- Drug: ACE-232 tablets
Primary outcomes (3)
- measure
- 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
- description
- Number of patients with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination, etc.
- measure
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.