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A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

31. juli 2026 oppdatert av: Flare Therapeutics Inc.

A Phase 1, First-in-Human, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FX-111 in Patients With Metastatic Castration-Resistant Prostate Cancer

The goal of this clinical trial is to find out if FX-111 is safe enough to permit further studies in adult male participants with metastatic castration-resistant prostate cancer (mCRPC). It will also study the drug's pharmacokinetics (how the body breaks down FX-111) and how well FX-111 treats mCRPC. The main questions it aims to answer are:

What are the side effects of FX-111?

Does FX-111 work to reduce or prevent progression of mCRPC?

The study doctor will oversee participants' treatment with FX-111 and ask about any side effects. Participants will take FX-111 every day by mouth and will have regular physical and laboratory examinations to check health and tumor status.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiekontakt

  • Navn: Janine Koucheki, Associate Director, Clinical Operations
  • Telefonnummer: 857-706-4400
  • E-post: clinops@flaretx.com

Studer Kontakt Backup

  • Navn: Carolyn McCrone, Sr Clinical Trial Associate
  • Telefonnummer: 857-706-4400
  • E-post: clinops@flaretx.com

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90025
        • Rekruttering
        • START Los Angeles
        • Ta kontakt med:
        • Hovedetterforsker:
          • Navid Hafez, MD, MPH
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Har ikke rekruttert ennå
        • Massachusetts General Hospital
        • Hovedetterforsker:
          • Xin Gao, MD
    • Michigan
      • Grand Rapids, Michigan, Forente stater, 49546
        • Rekruttering
        • START MidWest
        • Hovedetterforsker:
          • Emerson Lim, MD
        • Ta kontakt med:
    • New Jersey
      • East Brunswick, New Jersey, Forente stater, 08816
        • Rekruttering
        • START New Jersey
        • Hovedetterforsker:
          • Bruno Fang, MD
        • Ta kontakt med:
    • South Carolina
      • Myrtle Beach, South Carolina, Forente stater, 29572
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • Har ikke rekruttert ennå
        • Tennessee Oncology
        • Hovedetterforsker:
          • Katy Beckermann, MD, Ph.D.
    • Texas
      • Fort Worth, Texas, Forente stater, 76104
        • Rekruttering
        • START Dallas-Fort Worth
        • Ta kontakt med:
        • Hovedetterforsker:
          • Salwan Al Mutar, MD, M.Sc.
      • Houston, Texas, Forente stater, 77054
        • Rekruttering
        • NEXT Houston
        • Hovedetterforsker:
          • Jennifer Segar, MD
        • Ta kontakt med:
      • San Antonio, Texas, Forente stater, 78229
        • Rekruttering
        • NEXT Oncology
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ildefonso Ismael Rodriguez Rivera, MD
    • Virginia
      • Fairfax, Virginia, Forente stater, 22031
        • Rekruttering
        • NEXT Virginia
        • Hovedetterforsker:
          • Mohamad Salkeni, MD
        • Ta kontakt med:

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Confirmed adenocarcinoma of the prostate.
  • PSA levels ≥ 2 ng/mL at screening visit.
  • Progressing PSA, defined as two consecutive increases in the most recent PSA measurements taken at least 1 week apart.
  • Progressed on Androgen Deprivation Therapy (ADT) and at least one prior potent Androgen Receptor (AR) pathway inhibitor given in castration-sensitive prostate cancer setting or approved for castration-resistant prostate cancer (eg, apalutamide, darolutamide, abiraterone, enzalutamide).
  • Ongoing primary ADT with gonadotropin-releasing hormone agonist or antagonist in the absence of bilateral orchiectomy.
  • Acceptable physical functioning and laboratory measurements, per the study protocol.
  • Discontinued prior therapies within protocol-specified timeframes.
  • Commit to use of highly-effective contraception while on study and for 90 days after.
  • Willing and able to adhere to the study visit schedule and other protocol defined requirements.

Exclusion Criteria:

  • Predominance of small cell carcinoma of the prostate/neuroendocrine prostate cancer in most recent tumor biopsy.
  • Participants with brain metastases that require ongoing treatment with radiation or high-dose steroids.
  • Not recovered from side effects of prior surgery or cancer treatments.
  • Evidence of active viral, bacterial, or fungal infection requiring treatment with antivirals, antibiotics, or anti-fungal medications.
  • Prior treatment with AR degraders and molecules with an AR ligand such as AR Regulated Induced Proximity Targeting Chimera (RIPTAC).
  • Blood clots ≤ 4 weeks prior to start of treatment.
  • Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study drug. Patients may be eligible if the malignancy is clinically stable or has been treated with curative intent.
  • Any evidence of severe or uncontrolled systemic diseases.
  • Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.

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: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: FX-111 Dose Level 1
Legemiddel: FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
Eksperimentell: FX-111 Dose Level 2
Legemiddel: FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
Eksperimentell: FX-111 Dose Level 3
Legemiddel: FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
Eksperimentell: FX-111 Dose Level 4
Legemiddel: FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
Eksperimentell: FX-111 Dose Level 5
Legemiddel: FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
The number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111
Tidsramme: Study day 1 throughout the study, estimated to be 6 months.
Study day 1 throughout the study, estimated to be 6 months.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Area Under the Concentration Time Curve
Tidsramme: Study day 1 throughout the study for 6 months.
Total body exposure of FX-111
Study day 1 throughout the study for 6 months.
Maximum concentration (Cmax) of FX-111 in the bloodstream.
Tidsramme: Study day 1 throughout the study for 6 months.
Study day 1 throughout the study for 6 months.
Time required (Tmax) to reach Cmax of FX-111 in the bloodstream.
Tidsramme: Study day 1 throughout the study for 6 months.
Study day 1 throughout the study for 6 months.
Rate of confirmed prostate-specific antigen (PSA) decline of ≥ 50% from baseline (PSA50).
Tidsramme: Baseline and every 4 weeks throughout the study, estimated to be 6 months.
Baseline and every 4 weeks throughout the study, estimated to be 6 months.
Objective Response Rate (ORR)
Tidsramme: Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.

The number of patients who achieve either a Complete Response (CR) or Partial Response (PR) to FX-111.

CR: disappearance of all lesions and pathologic lymph nodes. PR: ≥30% decrease in sum of lesions, no new lesions, no progression of non-target lesions.
Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.
Duration of Response (DoR)
Tidsramme: Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.
DoR is the time from initial CR or PR until disease progression.
Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.

Samarbeidspartnere og etterforskere

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

Sponsor

Flare Therapeutics Inc.

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)

1. juli 2026

Primær fullføring (Antatt)

15. februar 2028

Studiet fullført (Antatt)

15. februar 2029

Datoer for studieregistrering

Først innsendt

17. juli 2026

Først innsendt som oppfylte QC-kriteriene

17. juli 2026

Først lagt ut (Faktiske)

22. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FX-111-CLINPRO-1

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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