ACE-232 for Prostate Cancer

Recruiting at 8 trial locations

Overseen By Teresa Shi

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Acerand Therapeutics (Hong Kong) Limited

Must be taking: Androgen deprivation therapy

Must not be taking: CYP3A4 inhibitors, P-gp inhibitors

Disqualifiers: Brain metastases, Cardiovascular disorders, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

67 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{3 6 7 8 9}

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

Provide written informed consent

I am fully active or can carry out light work.

Has a life expectancy of at least 6 months

Exclusion Criteria

I have severe heart problems.

My diabetes is not well-managed.

Known allergy or hypersensitivity to any of the excipients of ACE-232

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1A Dose Escalation

Assess safety, tolerability, pharmacokinetics, and pharmacodynamics to determine the maximum tolerated dose (MTD) of ACE-232

4 weeks

Phase 1B Dose Optimization

Patients with AR gene alterations are treated at two different dose levels to establish the recommended Phase 2 dose (RP2D)

Up to 37 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: ACE-232 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Acerand Therapeutics (Hong Kong) Limited

Lead Sponsor

Trials

1

Recruited

70+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06801236

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 ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/569656

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 ...

3. acerand.com acerand.com/nw_20250410.html

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 ...

4. urologytimes.com urologytimes.com/view/phase-1-study-launches-of-novel-cyp11a1-inhibitor-for-mcrpc

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_inhibitor

a 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- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06801236

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-and

Discovery 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 ...

8. acerand.com acerand.com/nw_20250604.html

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-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 ...