NCT06801236

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P75+ for phase_1

Timeline
27mo left

Started May 2025

Typical duration for phase_1

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
May 2025Aug 2028

First Submitted

Initial submission to the registry

January 19, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 12, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

April 9, 2026

Status Verified

December 1, 2025

Enrollment Period

2.8 years

First QC Date

January 19, 2025

Last Update Submit

April 8, 2026

Conditions

Prostate Cancer (Adenocarcinoma)mCRPC (Metastatic Castration-resistant Prostate Cancer)

Keywords

ACE-232castration-resistant prostate cancerCRPCHormone AntagonistsHormone SubstitutesAntineoplastic AgentsProstatic NeoplasmsCastration-Resistantprostate cancerCYP11A1

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Up to approximately 37 months

Secondary Outcomes (8)

  • Pharmacokinetics characterization by using Area under the plasma concentration versus time curve (AUC)

    Up to approximately 37 months

  • Pharmacokinetics characterization by using Maximum concentration (Cmax)

    Up to approximately 37 months

  • Prostate Specific Antigen (PSA) response

    Up to approximately 37 months

  • Objective Response Rate (ORR)

    Up to approximately 37 months

  • Duration of Response (DoR)

    Up to approximately 37 months

  • +3 more secondary outcomes

Other Outcomes (1)

  • Gene aberrations

    Up to approximately 37 months

Study Arms (1)

ACE-232

EXPERIMENTAL
Drug: ACE-232 tablets

Interventions

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.

ACE-232

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of California San Diego, Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

Moffitt Cancer Center, Tampa

Tampa, Florida, 33612, United States

RECRUITING

University of Maryland, Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

Harvard Medical School-Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

Xcancer (Urology Cancer Center)

Omaha, Nebraska, 68130, United States

RECRUITING

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Central Study Contacts

Sherwin Cai, MD

CONTACT

86-18983021726sherwin.cai@acerand.com

Teresa Shi, MS

CONTACT

86-13916513539teresa.shi@acerand.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2025

First Posted

January 30, 2025

Study Start

May 12, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

April 9, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

No IPD sharing plan at this moment, which might be changed during the study process or when the results come out.

Locations

US(8)