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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
- Fáze 1
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: K-1728 Monotherapy
Participants receive K-1728 orally as monotherapy |
K-1728 will be administered orally once daily in 28-day cycles |
|
Experimentální: 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 |
|
Experimentální: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Maximum Tolerated Dose (MTD)/Maximum Efficacious Dose (MED) and Recommended Phase 2 Dose (RP2D)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pharmacokinetics - Maximum Plasma Concentration (Cmax) of K-1728
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle místa
- Novotvary
- Kožní choroby
- Nemoci prsu
- Onemocnění kůže a pojivové tkáně
- Novotvary prsu
- Hormony
- Hormony, hormonální náhražky a antagonisté hormonů
- Polycyklické sloučeniny
- Steroidy
- Sloučeniny roztaveného kruhu
- Estradiol
- Estreny
- Estranes
- Estradiolové kongenery
- Gonadal steroidní hormony
- Gonadální hormony
- Fulvestrant
- Palbociclib
Další identifikační čísla studie
- K-1728-1001
Plán pro data jednotlivých účastníků (IPD)
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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