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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
- 1단계
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: K-1728 Monotherapy
Participants receive K-1728 orally as monotherapy |
K-1728 will be administered orally once daily in 28-day cycles |
|
실험적: 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 |
|
실험적: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Maximum Tolerated Dose (MTD)/Maximum Efficacious Dose (MED) and Recommended Phase 2 Dose (RP2D)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pharmacokinetics - Maximum Plasma Concentration (Cmax) of K-1728
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- K-1728-1001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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