A Phase 1/2a Study of K-1728 in Advanced Solid Tumors (PIKYMA-01)
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 2
- Vaihe 1
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Peräkkäinen tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: K-1728 Monotherapy
Participants receive K-1728 orally as monotherapy |
K-1728 will be administered orally once daily in 28-day cycles |
|
Kokeellinen: K-1728 + Endocrine Therapy
Participants receive K-1728 orally in combination with endocrine therapy |
K-1728 will be administered orally once daily in 28-day cycles Fulvestrant will be administered intramuscularly on Days 1 and 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle |
|
Kokeellinen: K-1728 + Endocrine Therapy + CDK4/6 Inhibitor
Participants receive K-1728 orally in combination with endocrine therapy and a CDK4/6 inhibitor |
K-1728 will be administered orally once daily in 28-day cycles Fulvestrant will be administered intramuscularly on Days 1 and 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle Palbociclib will be administered orally on Days 1-21 in 28-day cycles |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Maximum Tolerated Dose (MTD)/Maximum Efficacious Dose (MED) and Recommended Phase 2 Dose (RP2D)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Pharmacokinetics - Maximum Plasma Concentration (Cmax) of K-1728
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat sivustoittain
- Neoplasmat
- Ihosairaudet
- Rintojen sairaudet
- Iho- ja sidekudostaudit
- Rintojen kasvaimet
- Hormonit
- Hormonit, hormonikorvikkeet ja hormoniantagonistit
- Polisykliset yhdisteet
- Steroidit
- Sulatettu rengasyhdisteet
- Estradioli
- Esreenit
- Estaanit
- Estradioli -yhdistäjät
- Gonadal -steroidihormonit
- Gonadal -hormonit
- Fulvestrantti
- palbociclib
Muut tutkimustunnusnumerot
- K-1728-1001
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