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A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

31. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse Kontakt Backup

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

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90025
        • Rekruttering
        • START Los Angeles
        • Kontakt:
        • Ledende efterforsker:
          • Navid Hafez, MD, MPH
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Ikke rekrutterer endnu
        • Massachusetts General Hospital
        • Ledende efterforsker:
          • Xin Gao, MD
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49546
        • Rekruttering
        • START MidWest
        • Ledende efterforsker:
          • Emerson Lim, MD
        • Kontakt:
    • New Jersey
      • East Brunswick, New Jersey, Forenede Stater, 08816
        • Rekruttering
        • START New Jersey
        • Ledende efterforsker:
          • Bruno Fang, MD
        • Kontakt:
    • South Carolina
      • Myrtle Beach, South Carolina, Forenede Stater, 29572
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Ikke rekrutterer endnu
        • Tennessee Oncology
        • Ledende efterforsker:
          • Katy Beckermann, MD, Ph.D.
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104
        • Rekruttering
        • START Dallas-Fort Worth
        • Kontakt:
        • Ledende efterforsker:
          • Salwan Al Mutar, MD, M.Sc.
      • Houston, Texas, Forenede Stater, 77054
      • San Antonio, Texas, Forenede Stater, 78229
        • Rekruttering
        • NEXT Oncology
        • Kontakt:
        • Ledende efterforsker:
          • Ildefonso Ismael Rodriguez Rivera, MD
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
        • Rekruttering
        • NEXT Virginia
        • Ledende efterforsker:
          • Mohamad Salkeni, MD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: FX-111 Dose Level 1
Medicin: FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
Eksperimentel: FX-111 Dose Level 2
Medicin: FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
Eksperimentel: FX-111 Dose Level 3
Medicin: FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
Eksperimentel: FX-111 Dose Level 4
Medicin: FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
Eksperimentel: FX-111 Dose Level 5
Medicin: FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Flare Therapeutics Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2026

Primær færdiggørelse (Anslået)

15. februar 2028

Studieafslutning (Anslået)

15. februar 2029

Datoer for studieregistrering

Først indsendt

17. juli 2026

Først indsendt, der opfyldte QC-kriterier

17. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FX-111-CLINPRO-1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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