Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Fas 1-studie av ACE-232 för att behandla patienter med metastaserande kastreringsresistent prostatacancer

24 september 2026 uppdaterad av: Acerand Therapeutics (Hong Kong) Limited

En fas 1-studie för att bedöma säkerhet, farmakokinetik, farmakodynamik och preliminär effekt av ACE-232 hos patienter med metastaserande kastreringsresistent prostatacancer (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).

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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).

Studietyp

Interventionell

Inskrivning (Beräknad)

88

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • California
      • La Jolla, California, Förenta staterna, 92093
        • Rekrytering
        • University of California San Diego, Moores Cancer Center
    • Florida
      • Tampa, Florida, Förenta staterna, 33612
        • Rekrytering
        • Moffitt Cancer Center, Tampa
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21201
        • Rekrytering
        • University of Maryland, Greenebaum Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02114
        • Rekrytering
        • Harvard Medical School-Massachusetts General Hospital
    • Minnesota
      • Minneapolis, Minnesota, Förenta staterna, 55455
        • Rekrytering
        • M Health Fairview Clinics and Surgery Center
    • Nebraska
      • Omaha, Nebraska, Förenta staterna, 68130
        • Indragen
        • Xcancer (Urology Cancer Center)
    • South Carolina
      • Myrtle Beach, South Carolina, Förenta staterna, 29572
        • Rekrytering
        • Carolina Urologic Research Center
    • Washington
      • Seattle, Washington, Förenta staterna, 98109
        • Rekrytering
        • Fred Hutchinson Cancer Research Center
  • Kina
    • China
      • Beijing, China, Kina, 102200
      • Hangzhou, China, Kina, 310022
        • Har inte rekryterat ännu
        • Zhejiang Cancer Hospital
        • Kontakt:
      • Shanghai, China, Kina, 200127
        • Har inte rekryterat ännu
        • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Kontakt:
      • Zhengzhou, China, Kina, 450008
        • Har inte rekryterat ännu
        • Henan Cancer Hospital
        • Kontakt:
    • Fujian
      • Fuzhou, Fujian, Kina
        • Rekrytering
        • Fujian Cancer Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: ACE-232

Administered once daily (QD) continuously at the assigned dose level in accordance with the standard 3+3 dose-escalation scheme
Läkemedel: ACE-232 tablets

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of patients experiencing adverse events (AEs)/serious adverse events (SAEs)
Tidsram: From time of information consent to 30 days post last dose, up to approximately 37 months

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
Tidsram: 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)

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)
Tidsram: Up to approximately 37 months

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pharmacokinetics characterization by using Area under the plasma concentration versus time curve (AUC)
Tidsram: Up to approximately 37 months

To determine the pharmacokinetics (PK) using AUC of ACE-232 after a single dose and at steady state after multiple doses.
Up to approximately 37 months
Pharmacokinetics characterization by using Maximum concentration (Cmax)
Tidsram: Up to approximately 37 months

To determine the pharmacokinetics (PK) using Cmax of ACE-232 after a single dose and at steady state after multiple doses
Up to approximately 37 months
Prostate Specific Antigen (PSA) response
Tidsram: Up to approximately 37 months

PSA response is defined as PSA decline of 30% and 50% from baseline at any time point
Up to approximately 37 months
Objective Response Rate (ORR)
Tidsram: Up to approximately 37 months

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.
Up to approximately 37 months
Duration of Response (DoR)
Tidsram: Up to approximately 37 months

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.
Up to approximately 37 months
Radiographic Progression Free Survival (rPFS)
Tidsram: Up to approximately 37 months

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.
Up to approximately 37 months
Overall Survival (OS)
Tidsram: Up to approximately 37 months

OS is defined as the time from the first dose of ACE-232 to the date of death due to any cause.
Up to approximately 37 months
Blood concentration of steroid hormone
Tidsram: Up to approximately 37 months

To determine the blood concentration of steroid hormones at various timepoints and change from baseline
Up to approximately 37 months

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Gene aberrations
Tidsram: Up to approximately 37 months

To determine the gene aberrations in circulating tumor DNA (ctDNA), and its association with tumor response or resistance to ACE-232
Up to approximately 37 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Acerand Therapeutics (Hong Kong) Limited

Utredare

  • Studierektor: Derek Yang, MD, Acerand Therapeutics

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 maj 2025

Primärt slutförande (Beräknad)

31 december 2028

Avslutad studie (Beräknad)

31 december 2028

Studieregistreringsdatum

Först inskickad

19 januari 2025

Först inskickad som uppfyllde QC-kriterierna

24 januari 2025

Första postat (Faktisk)

30 januari 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ACE-232-001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera