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En studie av INCB099280 i kombinasjon med axitinib hos voksne med avanserte solide svulster

8. mai 2026 oppdatert av: Incyte Corporation

En fase 1/2-studie av INCB099280 i kombinasjon med axitinib hos voksne med avanserte solide svulster

Denne studien blir utført for å evaluere sikkerheten og toleransen til INCB099280 i kombinasjon med axitinib og for å vurdere antitumoraktiviteten til INCB099280 i kombinasjon med axitinib.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

5

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

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

Studiesteder

  • Storbritannia
      • Cambridge, Storbritannia, CB2 0QQ
        • Addenbrookes Hospital
      • Glasgow, Storbritannia, G12 0YN
        • Beatson West of Scotland Cancer Centrewester
      • London, Storbritannia, SE1 9RT
        • Guys Hospital
      • London, Storbritannia, EC1A 7BE
        • St Bartholomew's Hospital
      • London, Storbritannia, SW3 6JJ
        • The Royal Marsden
      • Sutton, Storbritannia, SM2 5PT
        • The Royal Marsden Nhs Foundation Trust - Sutton

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

Inklusjonskriterier:

  • Histologisk bekreftede avanserte solide svulster (protokolldefinerte utvalgte solide svulster) med målbare lesjoner i henhold til responsevalueringskriterier i solide svulster versjon 1.1 (RECIST v1.1) som anses som ikke mottagelig for kirurgi eller andre kurative behandlinger eller prosedyrer.
  • Må ha sykdomsprogresjon på eller etter behandling med minst én tidligere systemisk kjemoterapi.
  • Eastern Cooperative Oncology Group resultatstatusscore på 0 eller 1.
  • Forventet levealder > 12 uker.
  • Vilje til å unngå graviditet.

Ekskluderingskriterier:

  • Kjent ytterligere malignitet som utvikler seg eller krever aktiv behandling.
  • Metastaser i sentralnervesystemet (CNS) som krever behandling og/eller leptomeningeal sykdom.
  • Toksisitet fra tidligere behandling som ikke har kommet seg til protokolldefinerte grenser.
  • Forutgående mottak av et anti-PD-1-, anti-PD-L1- eller anti-PD-L2-middel; behandling med en immunmodulator (f.eks. CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T-celle).
  • Tidligere terapi med antiangiogene småmolekylære TKI-er rettet mot VEGF-veien
  • Deltakelse i en annen intervensjonell klinisk studie mens du mottar INCB099280.
  • Nedsatt hjertefunksjon eller klinisk signifikant hjertesykdom.
  • Anamnese eller bevis på interstitiell lungesykdom inkludert ikke-infeksiøs pneumonitt.
  • Tilstedeværelse av gastrointestinale tilstander som kan påvirke legemiddelabsorpsjonen.
  • Enhver autoimmun sykdom som krever systemisk behandling de siste 5 årene.
  • Diagnostisering av primær immunsvikt eller mottar kronisk systemisk steroidbehandling med en daglig dose over 10 mg prednison eller tilsvarende.
  • Aktiv infeksjon som krever systemisk terapi.
  • Historie om organtransplantasjon, inkludert stamcelletransplantasjon.
  • Mottak av systemisk antibiotika innen 28 dager etter første dose av studiebehandlingen.
  • Probiotikabruk er forbudt under screening og gjennom hele studiebehandlingsperioden.
  • Fikk en levende vaksine innen 28 dager etter planlagt oppstart av studiemedikamentet.
  • Laboratorieverdier utenfor de protokolldefinerte områdene.
  • Utilstrekkelig organfunksjon.

Andre protokolldefinerte inkluderings-/ekskluderingskriterier kan gjelde.

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: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Del 1: Doseeskalering
Opptil 6 doser INCB099280 administrert to ganger daglig (BID) i kombinasjon med axitinib BID vil bli evaluert for å identifisere dose(r) for videre evaluering i doseutvidelsesfasen av studien.
Legemiddel: INCB099280
Administreres som spesifisert i behandlingsarmbeskrivelsen
Legemiddel: axitinib
Administreres som spesifisert i behandlingsarmbeskrivelsen
Eksperimentell: Del 2: Doseutvidelse
Når del 1 er fullført, vil deltakerne bli registrert i 1 av 2 sykdomsspesifikke kohorter: Kohort 1: Voksne med klarcellet gynekologisk kreft med minst 50 % klarcellet histologi hvis sykdom progredierte på eller etter minst 1 tidligere linje av systemisk kjemoterapi og er ikke kandidater for kurativ kirurgi eller (kjemo)stråling. Kohort 2: Voksne med sjeldne histologiske subtype epitelkreft i den gynekologiske trakten hvis sykdom progredierte på eller etter minst 1 tidligere linje med systemisk kjemoterapi og som ikke er kandidater for kurativ kirurgi eller (kjemo)stråling. Én eller to doser kan velges fra del 1 for hver kohort i del 2-utvidelsen.
Legemiddel: INCB099280
Administreres som spesifisert i behandlingsarmbeskrivelsen
Legemiddel: axitinib
Administreres som spesifisert i behandlingsarmbeskrivelsen

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Tidsramme: up to 3 weeks
Any adverse event that ws at least possibly related to study treatment and met protocol-specified criteria was classified as a DLT. For the purpose of dose finding, decisions on dose were based on DLTs observed during the first 21 days of treatment.
up to 3 weeks
Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Tidsramme: up to approximately 1 year
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
up to approximately 1 year
Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)
Tidsramme: up to approximately 1 year
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
up to approximately 1 year
Part 2: Objective Response
Tidsramme: up to 2 years
Objective response was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
up to 2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Part 2: Number of Participants With Any TEAE
Tidsramme: up to 2 years
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
up to 2 years
Part 2: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)
Tidsramme: up to 2 years
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
up to 2 years
Part 1: Objective Response
Tidsramme: up to 335 days
Objective response was defined as the percentage of participants with a BOR of CR or PR by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
up to 335 days
Part 1: Disease Control
Tidsramme: up to 335 days
Disease control was defined as the percentage of participants with a BOR of CR, PR, or stable disease (SD) by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to 335 days
Part 1: Duration of Response (DOR)
Tidsramme: up to 335 days
DOR was defined as the time from the first CR or PR until disease progression by investigator assessment per RECIST v1.1 or death from any cause, whichever occurred earlier. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
up to 335 days
Part 1: INCB099280 and Axitinib Plasma Concentrations
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Blood samples were collected for the analysis of INCB099280 and axitinib concentrations. Per Protocol, PK samples for axitinib were only to be analyzed in case of a concern that axitinib was not as active as expected. Due to the early termination of the study before readout, these samples were not analyzed.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Cmax of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Cmax was defined as the maximum observed concentration of INCB099280.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Tmax of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
tmax was defined as the time to the maximum concentration of INCB099280.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: AUC0-4h of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
AUC0-4h was defined as area under the steady-state plasma or serum concentration-time curve from 0 to 4 hours.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Cmax,ss of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Cmax,ss was defined as the maximum observed concentration at steady state.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Tmax,ss of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
tmax,ss was defined as the time to the maximum concentration of INCB099280 at steady state.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: AUC0-12h of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
AUC0-12h was defined as the area under the steady-state plasma or serum concentration-time curve from 0 to 12 hours.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Cavg of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Cavg was defined as the average concentration of INCB099280.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Ctau of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Ctau was defined as the concentration of INCB099280 at the end of a dose interval.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: t1/2 of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
t1/2 was defined as the apparent terminal-phase disposition half life of INCB099280.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: CLss/F of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
CLss/F was defined as the apparent oral dose clearance of INCB099280 at steady state.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Vz/F of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Vz/F was defined as the apparent oral dose volume of distribution of INCB099280.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

Samarbeidspartnere og etterforskere

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

Sponsor

Incyte Corporation

Etterforskere

  • Studieleder: Philomena Colucci, Incyte Corporation

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)

16. april 2024

Primær fullføring (Faktiske)

6. juni 2025

Studiet fullført (Faktiske)

6. juni 2025

Datoer for studieregistrering

Først innsendt

10. juli 2023

Først innsendt som oppfylte QC-kriteriene

10. juli 2023

Først lagt ut (Faktiske)

18. juli 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • INCB99280-201
  • 2022-003663-13 (EudraCT-nummer: CTIS (EU))
  • 2023-510281-27-00 (Registeridentifikator: EU CT Number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Incyte deler data med kvalifiserte eksterne forskere etter at et forskningsforslag er sendt inn. Disse forespørslene vurderes og godkjennes av et granskingspanel på grunnlag av vitenskapelig fortjeneste. Alle data som oppgis er anonymisert for å respektere personvernet til pasienter som har deltatt i forsøket i tråd med gjeldende lover og forskrifter. Tilgjengeligheten av prøvedata er i henhold til kriteriene og prosessen beskrevet på https://www.incyte.com/our-company/compliance-and-transparency

IPD-delingstidsramme

Data vil bli delt etter primærpublisering eller 2 år etter at studien er avsluttet for markedsautoriserte produkter og indikasjoner.

Tilgangskriterier for IPD-deling

Data fra kvalifiserte studier vil bli delt med kvalifiserte forskere i henhold til kriteriene og prosessen beskrevet i delen for datadeling på www.incyteclinicaltrials.com nettsted. For godkjente forespørsler vil forskerne få tilgang til anonymiserte data under vilkårene i en datadelingsavtale.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere