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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：K-1728 Monotherapy
Participants receive K-1728 orally as monotherapy |
K-1728 will be administered orally once daily in 28-day cycles |
|
実験的：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 |
|
実験的：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum Tolerated Dose (MTD)/Maximum Efficacious Dose (MED) and Recommended Phase 2 Dose (RP2D)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pharmacokinetics - Maximum Plasma Concentration (Cmax) of K-1728
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- K-1728-1001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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