Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ACE-232 tablets.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (Adenocarcinoma), mCRPC (Metastatic Castration-resistant Prostate Cancer). Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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).
Detailed description
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).
Interventions
- Drug ACE-232 tablets
ACE-232 tablets will be administered orally daily as a continuous regimen together with Dexamethasone and Fludrocortisone. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
Primary outcome measures
- Number of patients experiencing adverse events (AEs)/serious adverse events (SAEs) [Time frame: From time of information consent to 30 days post last dose, up to approximately 37 months]
- Number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol [Time frame: 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)]
- Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) [Time frame: Up to approximately 37 months]
Secondary outcome measures (8)
- Pharmacokinetics characterization by using Area under the plasma concentration versus time curve (AUC) [Time frame: Up to approximately 37 months]
- Pharmacokinetics characterization by using Maximum concentration (Cmax) [Time frame: Up to approximately 37 months]
- Prostate Specific Antigen (PSA) response [Time frame: Up to approximately 37 months]
- Objective Response Rate (ORR) [Time frame: Up to approximately 37 months]
- Duration of Response (DoR) [Time frame: Up to approximately 37 months]
- Radiographic Progression Free Survival (rPFS) [Time frame: Up to approximately 37 months]
- Overall Survival (OS) [Time frame: Up to approximately 37 months]
- Blood concentration of steroid hormone [Time frame: Up to approximately 37 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- University of California San Diego, Moores Cancer Center — La Jolla
- Moffitt Cancer Center, Tampa — Tampa
- University of Maryland, Greenebaum Comprehensive Cancer Center — Baltimore
- Harvard Medical School-Massachusetts General Hospital — Boston
- M Health Fairview Clinics and Surgery Center — Minneapolis
- Xcancer (Urology Cancer Center) — Omaha
- Carolina Urologic Research Center — Myrtle Beach
- Fred Hutchinson Cancer Research Center — Seattle
China · 1 center
- Fujian Cancer Hospital — Fuzhou
Identifiers
NCT: NCT06801236 · ACE-232-001