ACE-232 for Prostate Cancer

Recruiting at 6 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

Trial Summary

What is the purpose of this trial?

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).

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.

How does the drug ACE-232 differ from other prostate cancer treatments?

ACE-232 is unique because it targets the angiotensin-converting enzyme (ACE), which is involved in the regulation of blood pressure and may play a role in prostate cancer progression. This approach is different from standard treatments that typically focus on hormone levels or chemotherapy. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Linkage of angiotensin I-converting enzyme gene insertion/deletion polymorphism to the progression of human prostate cancer. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of role of angiotensin III and aminopeptidases in prostate cancer cells. [2017]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The role of angiotensin-converting enzyme and angiotensin ii receptors of the second type in the pathogenesis of proliferative diseases of the prostate]. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Association of angiotensin I converting enzyme polymorphism as genetic risk factor in benign prostatic hyperplasia and prostate cancer. [2016]

5. Greece pubmed.ncbi.nlm.nih.gov

Effects of ACE I/D polymorphism on prostate cancer risk, tumor grade and metastatis. [2007]