Prostate Cancer (Adenocarcinoma)Phase 1NCT06801236
Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study testing ACE-232 tablets in people with Prostate Cancer (Adenocarcinoma) and mCRPC (Metastatic Castration-resistant Prostate Cancer), run by Acerand Therapeutics (Hong Kong) Limited at 13 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), mCRPC (Metastatic Castration-resistant Prostate Cancer)
- What is being tested?
- ACE-232 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 12 May 2025to 31 Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
United States8 sites, 7 recruiting
- Recruiting
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
- Recruiting
Harvard Medical School-Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
University of California San Diego, Moores Cancer Center
La Jolla, California, 92093
- Recruiting
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota, 55455
- Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
- Withdrawn
Xcancer (Urology Cancer Center)
Omaha, Nebraska, 68130
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
- Recruiting
Moffitt Cancer Center, Tampa
Tampa, Florida, 33612
China5 sites, 5 recruiting
- Not yet recruiting
Beijing Gobroard Hospital
Beijing, China, 102200
86+400-696-2000, international.service@gobroadhealthcare.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, China, 310022
86-571-88122222, zjszlyy@163.com
- Not yet recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200127
86-21-58752345, renji@renji.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, China, 450008
86+400-0371-818, hnszlyyyb@163.com
About this study
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)
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).
Read the 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).
- Being tested
- ACE-232 tablets
- Keywords
- ACE-232, castration-resistant prostate cancer, CRPC, Hormone Antagonists, Hormone Substitutes, Antineoplastic Agents, Prostatic Neoplasms, Castration-Resistant, prostate cancer, CYP11A1
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE-232 tabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ACE-232 | Experimental | Administered once daily (QD) continuously at the assigned dose level in accordance with the standard 3+3 dose-escalation scheme Receives: Drug: ACE-232 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing adverse events (AEs)/serious adverse events (SAEs)
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.
Measured: 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
A DLT is defined as any toxicity events related to ACE-232 that occur from the first dose of study treatment until the planned end date of Cycle 1 (DLT assessment period), meeting the criteria specified in protocol.
Measured: 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)
RP2D will be finally determined by the SMC and sponsor based on all data from the dose escalation module and backfill module, as well as the exposure-response relationship evaluated (if available). MTD is defined as the maximum dose level at which ≤1 patient have DLTs during the DLT observation period, and it should be determined with 6 evaluable patients.
Measured: Up to approximately 37 months
Secondary outcomes (8)
Pharmacokinetics characterization by using Area under the plasma concentration versus time curve (AUC)
To determine the pharmacokinetics (PK) using AUC of ACE-232 after a single dose and at steady state after multiple doses.
Measured: Up to approximately 37 months
Pharmacokinetics characterization by using Maximum concentration (Cmax)
To determine the pharmacokinetics (PK) using Cmax of ACE-232 after a single dose and at steady state after multiple doses
Measured: Up to approximately 37 months
Prostate Specific Antigen (PSA) response
PSA response is defined as PSA decline of 30% and 50% from baseline at any time point
Measured: Up to approximately 37 months
Objective Response Rate (ORR)
ORR is defined as a complete response (CR) or partial response (PR), as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) and Prostate Cancer Working Group Criteria 3 (PCWG3 criteria), in patients with measurable disease at baseline.
Measured: Up to approximately 37 months
Duration of Response (DoR)
DOR is defined, for patients with an objective response, as the time from first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause.
Measured: Up to approximately 37 months
Radiographic Progression Free Survival (rPFS)
rPFS is defined as the time from the first dose of ACE-232 to the first documented disease progression by either RECIST progression and/or progression on bone scan by PCWG3 or death due to any cause, whichever occurs first.
Measured: Up to approximately 37 months
Overall Survival (OS)
OS is defined as the time from the first dose of ACE-232 to the date of death due to any cause.
Measured: Up to approximately 37 months
Blood concentration of steroid hormone
To determine the blood concentration of steroid hormones at various timepoints and change from baseline
Measured: Up to approximately 37 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start12 May 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acerand Therapeutics (Hong Kong) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Derek Yang, MD, Study director, Acerand Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801236
- Sponsor's protocol ID
- ACE-232-001
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing plan at this moment, which might be changed during the study process or when the results come out.