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A Phase 1/2a Study of K-1728 in Advanced Solid Tumors (PIKYMA-01)

1. oktober 2026 oppdatert av: KymaThera, Inc.

A First-in-Human Study of K-1728 Administered Alone and in Combination in Participants With Advanced or Metastatic Solid Tumors

This first-in-human, open-label, multicenter study evaluates K-1728 administered as monotherapy and in combination in participants with advanced or metastatic solid tumors. The study assesses the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of K-1728.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

110

Fase

  • Fase 2
  • Fase 1

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

Alle

Beskrivelse

Key Inclusion Criteria:

  • Adults with advanced or metastatic solid tumors who are able to provide consent
  • Documented activating PIK3CA mutation
  • ECOG performance status 0 or 1
  • Adequate organ function

Key Exclusion Criteria:

  • Active or untreated central nervous system disease
  • Clinical significant or uncontrolled cardiovascular disease
  • Significant or uncontrolled intercurrent illness
  • Pregnant or breastfeeding
  • Other protocol-defined exclusion criteria

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: K-1728 Monotherapy

Participants receive K-1728 orally as monotherapy
Legemiddel: K-1728

K-1728 will be administered orally once daily in 28-day cycles
Eksperimentell: K-1728 + Endocrine Therapy

Participants receive K-1728 orally in combination with endocrine therapy
Legemiddel: K-1728

K-1728 will be administered orally once daily in 28-day cycles

Legemiddel: Fulvestrant

Fulvestrant will be administered intramuscularly on Days 1 and 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle
Eksperimentell: K-1728 + Endocrine Therapy + CDK4/6 Inhibitor

Participants receive K-1728 orally in combination with endocrine therapy and a CDK4/6 inhibitor
Legemiddel: K-1728

K-1728 will be administered orally once daily in 28-day cycles

Legemiddel: Fulvestrant

Fulvestrant will be administered intramuscularly on Days 1 and 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle

Legemiddel: Palbociclib

Palbociclib will be administered orally on Days 1-21 in 28-day cycles

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximum Tolerated Dose (MTD)/Maximum Efficacious Dose (MED) and Recommended Phase 2 Dose (RP2D)
Tidsramme: Cycle 1 (28 days) through completion of dose escalation (up to approximately 24 months)

Determination of the MTD/MED and RP2D of K-1728 administered as monotherapy and in combination
Cycle 1 (28 days) through completion of dose escalation (up to approximately 24 months)
Incidence of Dose-Limiting Toxicities (DLTs)
Tidsramme: Initiation of study drug through Cycle 1 (28 days)

Number and percentage of participants experiencing a dose-limiting toxicity during the DLT-evaluation period with of K-1728 administered as monotherapy and in combination
Initiation of study drug through Cycle 1 (28 days)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)

Number and percentage of participants with adverse events and serious adverse events with K-1728 administered as a monotherapy and in combination
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Changes in laboratory parameters
Tidsramme: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)

Compared to baseline, changes in laboratory parameters with K-1728 administered as monotherapy and in combination
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Changes in vital signs
Tidsramme: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)

Compared to baseline, changes in vital signs with K-1728 administered as monotherapy and in combination
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Changes in electrocardiogram (ECG) parameters
Tidsramme: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)

Compared to baseline, changes in ECG parameters (including QT interval, QTc interval, QRS complex, and PR interval)
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Changes in physical examination
Tidsramme: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)

Compared to baseline, changes in physical examination
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pharmacokinetics - Maximum Plasma Concentration (Cmax) of K-1728
Tidsramme: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months

Cmax of K-1728 when administered as monotherapy or in combination
Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
Pharmacokinetics - Time to Maximum Plasma Concentration (Tmax) of K-1728
Tidsramme: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months

Tmax of K-1728 when administered as monotherapy or in combination
Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC) of K-1728
Tidsramme: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months

AUC of K-1728 when administered as monotherapy or in combination
Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
Pharmacokinetics - Half-life (t1/2) of K-1728 when administered as monotherapy or in combination
Tidsramme: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months

t1/2 of K-1728 when administered as monotherapy or in combination
Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
Preliminary Efficacy - Overall Response Rate (ORR)
Tidsramme: Initiation of study drug until disease progression, assessed up to approximately 24 months

Objective Response Rate (ORR) as assessed by RECIST v1.1
Initiation of study drug until disease progression, assessed up to approximately 24 months

Samarbeidspartnere og etterforskere

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

Sponsor

KymaThera, 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 (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. september 2028

Studiet fullført (Antatt)

1. mars 2029

Datoer for studieregistrering

Først innsendt

24. september 2026

Først innsendt som oppfylte QC-kriteriene

1. oktober 2026

Først lagt ut (Faktiske)

6. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • K-1728-1001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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