ACE-232 for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ACE-232, a potential drug for prostate cancer that has spread and resists standard hormone therapy. The main goal is to assess the treatment's safety and tolerability. It suits individuals with difficult-to-treat prostate cancer who are on hormone therapy and have not succeeded with other treatments. Participants should perform daily activities with minimal limitation. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you cannot use medications or supplements that affect certain liver enzymes or heart rhythms. There is also a washout period (time without taking certain medications) for anti-cancer drugs or treatments.
Is there any evidence suggesting that ACE-232 is likely to be safe for humans?
Research has shown that ACE-232 has promising safety results so far. In preclinical tests, conducted before human trials, ACE-232 was well-tolerated, causing few unwanted effects. It also performed as expected, without impacting other parts of the body.
Now in its first human trials, these early findings suggest ACE-232 has a wide safety margin, indicating a significant gap between safe doses and those that might cause issues. Since ACE-232 is in an early testing phase, the primary goal is to assess its safety for individuals with metastatic castration-resistant prostate cancer.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for prostate cancer, which often include hormone therapy, chemotherapy, or surgery, ACE-232 is unique because it targets a specific pathway involved in cancer cell growth. Researchers are excited about ACE-232 because it offers a novel mechanism of action that could potentially inhibit tumor progression more effectively. This targeted approach may lead to fewer side effects compared to traditional treatments, offering a promising new avenue for patients with prostate cancer.
What evidence suggests that ACE-232 might be an effective treatment for prostate cancer?
Research has shown that ACE-232, the investigational treatment in this trial, may effectively treat prostate cancer. In early studies, ACE-232 stopped tumor growth more effectively than treatments like ODM-208. It also reduced tumor size in mice, even at low doses. ACE-232 blocks an enzyme that produces hormones linked to cancer growth. These early results suggest that ACE-232 could be a strong option for treating advanced prostate cancer that no longer responds to standard hormone therapy.36789
Are You a Good Fit for This Trial?
This trial is for adults with metastatic castration-resistant prostate cancer. Participants must have a specific type of advanced prostate cancer that has spread and does not respond to hormone therapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1A Dose Escalation
Assess safety, tolerability, pharmacokinetics, and pharmacodynamics to determine the maximum tolerated dose (MTD) of ACE-232
Phase 1B Dose Optimization
Patients with AR gene alterations are treated at two different dose levels to establish the recommended Phase 2 dose (RP2D)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ACE-232
Trial Overview
The study tests ACE-232 tablets, an experimental treatment aimed at inhibiting CYP11A1, which may help in treating prostate cancer. It's an early-stage (phase 1) trial to assess safety, tolerability, and potential effectiveness against the cancer.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Acerand Therapeutics (Hong Kong) Limited
Lead Sponsor
Citations
NCT06801236 | Phase 1 Study of ACE-232 to Treat ...
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 ...
Phase 1 Study of ACE-232 to Treat Patients With Metastatic ...
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 ...
Acerand Announces Promising ACE-232 Preclinical Data ...
In these studies, ACE-232 showed superior tumor growth inhibition compared to ODM-208. Importantly, ACE-232 exhibited a favorable preclinical ...
Phase 1 study launches for novel CYP11A1 inhibitor ...
In preclinical studies, ACE-232 demonstrated superior potency, efficacy, and pharmacokinetic properties compared with other CYP11A1 inhibitors.
5.
researchgate.net
researchgate.net/publication/390987405_Abstract_6881_Discovery_of_ACE-232_a_novel_and_highly_potent_non-steroidal_CYP11A1_inhibitora novel and highly potent non-steroidal CYP11A1 inhibitor
In castrated mouse models, ACE-232 showed equal or superior efficacy in inhibiting tumor growth at 0.3 mg/kg QD in both VCaP and enzalutamide- ...
NCT06801236 | Phase 1 Study of ACE-232 to Treat ...
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 ...
7.
aacrjournals.org
aacrjournals.org/cancerres/article/85/8_Supplement_1/6881/759524/Abstract-6881-Discovery-of-ACE-232-a-novel-andDiscovery of ACE-232: a novel and highly potent non-steroidal ...
In a safety panel screening across 93 targets at 5 µM, ACE-232 exhibited minimal off-target effects. GLP toxicology studies demonstrated a wide ...
Acerand Therapeutics Initiates First-in-Human Phase 1 ...
ACE-232 showed excellent tolerability in preclinical models, presenting a wide therapeutic window for clinical development. The initiation of ...
9.
ctv.veeva.com
ctv.veeva.com/study/phase-1-study-of-ace-232-to-treat-patients-with-metastatic-castration-resistant-prostate-cancerPhase 1 Study of ACE-232 to Treat Patients With Metastatic ...
This is an open label, phase I, multi-center study aiming to assess the safety and tolerability in patients with metastatic castration resistant ...
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