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Fase 1-studie av ACE-232 for å behandle pasienter med metastatisk kastrasjonsresistent prostatakreft

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

En fase 1-studie for å vurdere sikkerhet, farmakokinetikk, farmakodynamikk og foreløpig effekt av ACE-232 hos pasienter med metastatisk kastrasjonsresistent prostatakreft (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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

88

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: ACE-232

Administered once daily (QD) continuously at the assigned dose level in accordance with the standard 3+3 dose-escalation scheme
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of patients experiencing adverse events (AEs)/serious adverse events (SAEs)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pharmacokinetics characterization by using Area under the plasma concentration versus time curve (AUC)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gene aberrations
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Acerand Therapeutics (Hong Kong) Limited

Etterforskere

  • Studieleder: Derek Yang, MD, Acerand Therapeutics

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. mai 2025

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

19. januar 2025

Først innsendt som oppfylte QC-kriteriene

24. januar 2025

Først lagt ut (Faktiske)

30. januar 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ACE-232-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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