Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer

27. april 2026 opdateret af: Faeth Therapeutics

Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced or Metastatic Breast Cancer

The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

32

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90025
        • Rekruttering
        • START Los Angeles
    • Oregon
      • Springfield, Oregon, Forenede Stater, 97477
        • Rekruttering
        • Oncology Associates of Oregon
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Rekruttering
        • SCRI Oncology Partners

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:

  • Histologically confirmed diagnosis of HR+/HER2- breast cancer.
  • Documented evidence of advanced or recurrent disease that is not amenable to surgery/radiation for curative intent.
  • Participant has received at least one prior systemic therapy.
  • At least 1 measurable or evaluable target lesion according to RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening.
  • Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods.

Exclusion Criteria:

  • Participants with triple-negative breast cancer.
  • Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.
  • Active malignancy (except for breast cancer, definitively treated in-situ carcinomas [e.g., breast, cervix, bladder], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible.
  • Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.
  • Significant cardiovascular impairment.
  • Active, uncontrolled infection.
  • Concurrent participation in another therapeutic clinical trial.
  • Prior radiation therapy within 21 days prior to start of study treatment.
  • Participants who have received a prior PI3K, AKT, mTORC1/2, or dual PI3K/mTOR inhibitor.
  • Strong CYP3A4 inhibitors, strong CYP1A2 inhibitors or CYP1A2 inducers, or clinically significant CYP3A4 inducers within 7 days before the first dose of study intervention, or participants who require treatment with strong CYP3A4 inhibitors or inducers during the study.
  • Prolongation of QTc interval to >480 ms.
  • Type 1 or Type 2 diabetes mellitus on insulin.

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: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort A1 - Sapanisertib and serabelisib (PIKTOR) with fulvestrant
Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and fulvestrant administered intramuscularly.
Medicin: Serabelisib
Serabelisib is a selective, small molecule inhibitor of PI3Kα.
Medicin: Sapanisertib
Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine/threonine kinase.
Medicin: Fulvestrant
Fulvestrant is a first-in-class SERD.
Eksperimentel: Cohort A2 - Sapanisertib and serabelisib (PIKTOR) with fulvestrant
Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) at a higher dose than Cohort A1 administered orally and fulvestrant administered intramuscularly.
Medicin: Serabelisib
Serabelisib is a selective, small molecule inhibitor of PI3Kα.
Medicin: Sapanisertib
Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine/threonine kinase.
Medicin: Fulvestrant
Fulvestrant is a first-in-class SERD.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs)
Tidsramme: 2 years
Graded according to the National Cancer Institute (NCI CTCAE v5.0).
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR)
Tidsramme: Up to 2 years.
Defined as the proportion of participants from the Response-Evaluable population who have confirmed best overall response of either CR or PR according to RECIST v1.1 as confirmed by the Investigator.
Up to 2 years.
Progression Free Survival (PFS)
Tidsramme: Up to 5 years.
Defined as the time from first dose to the date of the first evidence of disease progression or death.
Up to 5 years.
Progression Free Survival (PFS) at 6 months
Tidsramme: 6 months
Defined as the progression free survival (PFS) rate at 6 months.
6 months
Overall Survival (OS)
Tidsramme: Up to 5 years.
Defined as the time from first dose to the date of death due to any cause.
Up to 5 years.
Clinical Benefit Rate (CBR)
Tidsramme: Up to 5 years.
Defined as the percentage of participants from the All Treated population who achieve CR, PR, or SD.
Up to 5 years.
Duration of Response (DoR)
Tidsramme: Up to 5 years.
Defined for participants with a confirmed CR or PR as the time from response to the date of first evidence of disease progression or death.
Up to 5 years.

Samarbejdspartnere og efterforskere

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

Sponsor

Faeth Therapeutics

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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 (Anslået)

1. april 2026

Primær færdiggørelse (Anslået)

1. maj 2029

Studieafslutning (Anslået)

1. maj 2033

Datoer for studieregistrering

Først indsendt

17. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FTH-PIK-101

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 .

Kliniske forsøg med HR+ HER2- Brystkræft

Kliniske forsøg med Serabelisib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gabon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner