임상 레이더 AI | ||
|---|---|---|
임상시험 NCT06959615은(는) 진행된 고형 종양에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration 1상, 2상 334 용량 증량 오픈 라벨
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06959615은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 진행된 고형 종양에 대해 진행되며, 1상 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2024년 11월 22일에 시작되어 334명의 참여자를 모집하고 있습니다. Jacobio Pharmaceuticals Co., Ltd.이(가) 진행하며, 2027년 8월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 1월 20일에 갱신되었습니다.
간단한 개요
This is a multicenter, open-label, phase I/IIa to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of pan-KRAS inhibitor JAB-23E73 in patients with advanced solid tumors harboring KRAS mutations or amplification. The study consists of 2 phases: Phase 1 Dose Escalation and Phase IIa Dose Expansion.
상세한 설명
Study JAB-23E73-1001 is a global multicenter, open-label Phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anticancer activity of JAB-23E73 as a single agent in adult patients with advanced solid tumors with KRAS alteration. This study consists of a Phase 1a dose-escalation, followed by Phase 1b dose-expansion (dose optimization) and Phase 2a indication expansi...더 보기
공식 제목
A Multicenter, Open Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration
질환명
진행된 고형 종양기타 연구 식별자
- JAB-23E73-1001
NCT 번호
실제 연구 시작일
2024-11-22
최신 업데이트 게시
2026-01-20
예상 연구 완료일
2027-08-31
계획된 등록 인원
334
연구종류
중재연구
단계/상
1상
2상
2상
상태
모집중
키워드
KRAS
KRAS mutation
KRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A, KRAS G12D
Pan-KRAS
NSCLC
Pancreas cancer
Colorectal cancer
KRAS-mutant tumor
Targeted Therapy
JAB-23E73
KRAS mutation
KRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A, KRAS G12D
Pan-KRAS
NSCLC
Pancreas cancer
Colorectal cancer
KRAS-mutant tumor
Targeted Therapy
JAB-23E73
주요 목적
치료
설계 할당
비랜덤화 배정
중재 모델
순차설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Phase 1 Dose Exploration Monotherapy, dose escalation | JAB-23E73 Administered orally |
실험적Phase 2a Dose Expansion Monotherapy, dose expansion | JAB-23E73 Administered orally |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Phase 1: Number of participants with dose limiting toxicities (DLT) | Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. DLTs will be defined as the occurrence of any of the toxicities as described in the protocol. | Up to 21 days |
Phase 2a: Objective response rate (ORR) | ORR is defined as the proportion of patients with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1. | Up to approximately 2 years |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Phase 1/2a: Adverse events | Incidence and severity of treatment-emergent Adverse Events (TEAEs), treatment-related Adverse Events (TRAEs) and serious Adverse Events (SAEs) | Up to approximately 2 years |
Phase 1/2a: Pharmacokinetic (PK): Maximum concentration (Cmax) of JAB-23E73 | PK: Cmax of JAB-23E73 | Up to approximately 2 years |
Phase 1/2a: PK: Time to Maximum Concentration (Tmax) of JAB-23E73 | PK: Tmax of JAB-23E73 | Up to approximately 2 years |
Phase 1/2a: PK: Area Under the Concentration Versus Time Curve (AUC) of JAB-23E73 | PK: AUC of JAB-23E73 | Up to approximately 2 years |
Phase 1: ORR | ORR is defined as the proportion of patients with a BOR of confirmed CR or confirmed PR per RECIST v1.1. | Up to approximately 2 years |
Phase 1/2a: Time to Response (TTR) | TTR is defined as the time from the date of first dose of study drug to first documentation of response as assessed by the investigator per RECIST v1.1 | Up to approximately 2 years |
Phase 1/2a: Progression Free Survival (PFS) | PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of progressive disease assessed by the investigator per RECIST v1.1 or death, whichever occurs first. | Up to approximately 2 years |
Phase 1/2a: Disease Control Rate (DCR) | DCR is defined as the proportion of patients with CR, PR, or stable disease (SD) as assessed by the investigator per RECIST v1.1 | Up to approximately 2 years |
Phase 1/2a: Duration of Response (DoR) | DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator. | Up to approximately 2 years |
Phase 2a: Overall Survival (OS) | OS is defined as the time from the date of first dose of study drug until the date of death from any cause. | Up to approximately 2 years |
참여 도우미
적격성 기준
연령대
어린이, 성인, 노인
참여 가능한 성별
전체
- Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer with evidence of KRAS gene alteration (including gene mutation and wild type amplification).
- Able to provide an archived tumor tissue sample or fresh biopsy sample.
- Life expectancy ≥3 months at the start of treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- ≥1 measurable lesion per RECIST v1.1.
- Adequate organ function.
- Unable to swallow oral medications or with gastrointestinal dysfunction or gastrointestinal disease that significantly alters the absorption of medication.
- Previous treatment with rat sarcoma (RAS) targeting agents.
- Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.
- Impaired cardiovascular function or clinically significant cardiac disease.
- Mean QT interval corrected using Fridericia's formula (QTcF) >470 msec.
- Females who are pregnant or breastfeeding.
Jacobio Pharmaceuticals Co., Ltd.연구 대표 연락처
연락처: Jacobio Pharmaceuticals, 86 10 56315466, [email protected]
32 1개국에 임상시험 장소
Anhui
Anhui Provincial Cancer Hospital, Hefei, Anhui, 230001, China
대상자모집전
Beijing Municipality
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing Municipality, 100021, China
모집중
Beijing Cancer Hospital, Beijing, Beijing Municipality, 100032, China
모집중
Beijing Chest Hospital, Beijing, Beijing Municipality, 100032, China
모집중
Peking Union Medical College Hospital, Beijing, Beijing Municipality, 100032, China
모집중
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, 100050, China
대상자모집전
Fujian
Fujian cancer Hospital, Fuzhou, Fujian, 350014, China
대상자모집전
Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510120, China
모집중
Guangxi
Guangxi Medical University Cancer Hospital, Nanning, Guangxi, 530012, China
모집중
Hebei
National Cancer Center/Cancer Hospital- Langfang Campus, Chinese Academy of Medical Sciences and Peking Union Medical College, Langfang, Hebei, 065000, China
모집중
Heilongjiang
Harbin Medical University Cancer Hospital, Haerbin, Heilongjiang, 150081, China
모집중
Henan
Henan Cancer Hospital, Zhengzhou, Henan, 450003, China
모집중
The First Affiliated hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
모집중
Hubei
Tongji Hospital, Wuhan, Hubei, 430030, China
대상자모집전
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, China
모집중
Hunan
Hunan Cancer Hospital, Changsha, Hunan, 200032, China
대상자모집전
Jiangsu
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China
모집중
Jiangsu Cancer Hospital, Nanjing, Jiangsu, 210009, China
대상자모집전
Jiangsu Province Hospital, Nanjing, Jiangsu, 210029, China
모집중
The First Affiliate of Soochow University, Suzhou, Jiangsu, 215006, China
대상자모집전
Jiangxi
The First Affiliated hospital of Nanchang University, Nanchang, Jiangxi, 330006, China
모집중
Liaoning
The First Hospital of China Medical University, Shenyang, Liaoning, 110001, China
모집중
Shanghai Municipality
Shanghai Jiaotong University School of Medicine Ruijin Hospital, Shanghai, Shanghai Municipality, 200025, China
대상자모집전
Fudan University Zhongshan Hospital, Shanghai, Shanghai Municipality, 200032, China
대상자모집전
Huashan Hospital Fudan University, Shanghai, Shanghai Municipality, 200040, China
대상자모집전
Shanxi
ShanXi Cancer Hospital, Taiyuan, Shanxi, 650118, China
모집중
The First Affiliated hospital of Xi'an Jiaotong University, Xi’an, Shanxi, 710061, China
대상자모집전
Sichuan
West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China
대상자모집전
Tianjin Municipality
Tianjin Medical University Cancer Institute&Hospital, Tianjin, Tianjin Municipality, 300211, China
대상자모집전
Zhejiang
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310005, China
모집중
The Second Affiliate Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China
대상자모집전
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, China
대상자모집전