治験レーダーAI | ||
|---|---|---|
治験 NCT06959615（対象：進行固形腫瘍）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration 第I相・フェーズ1, 第II相・フェーズ2 334 用量漸増 非盲検
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06959615 は 進行固形腫瘍 に関する 治療 の研究で、第I相・フェーズ1 第II相・フェーズ2 介入研究 臨床試験 です。現在は 募集中 で、2024年11月22日 から開始しています。334 名の参加者 の募集が計画されています。この試験は Jacobio Pharmaceuticals Co., Ltd. によって主導され、2027年8月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年1月20日 です。
概要
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.
詳細説明
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...もっと見る
公式タイトル
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
疾患名
進行固形腫瘍その他の研究識別子
- JAB-23E73-1001
NCT番号
開始日
2024-11-22
最終更新日
2026-01-20
終了予定日
2027-08-31
目標参加者数
334
試験の種類
介入研究
治験の相・段階
第I相・フェーズ1
第II相・フェーズ2
第II相・フェーズ2
状況
募集中
キーワード
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
主目的
治療
割付方法
非無作為化
介入モデル
逐次割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Phase 1 Dose Exploration Monotherapy, dose escalation | JAB-23E73 Administered orally |
実験的Phase 2a Dose Expansion Monotherapy, dose expansion | JAB-23E73 Administered orally |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
参加アシスタント
適格基準
対象年齢
小児, 成人, 高齢者
対象性別
全て
- 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.試験中央連絡先
連絡先: Jacobio Pharmaceuticals, 86 10 56315466, [email protected]
32 1カ国の場所
Anhui
Anhui Provincial Cancer Hospital, Hefei, Anhui, 230001, China
募集準備中
Beijing Municipality
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing Municipality, 100021, China
募集中
Beijing Cancer Hospital, Beijing, Beijing Municipality, 100032, China
募集中
Beijing Chest Hospital, Beijing, Beijing Municipality, 100032, China
募集中
Peking Union Medical College Hospital, Beijing, Beijing Municipality, 100032, China
募集中
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, 100050, China
募集準備中
Fujian
Fujian cancer Hospital, Fuzhou, Fujian, 350014, China
募集準備中
Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510120, China
募集中
Guangxi
Guangxi Medical University Cancer Hospital, Nanning, Guangxi, 530012, China
募集中
Hebei
National Cancer Center/Cancer Hospital- Langfang Campus, Chinese Academy of Medical Sciences and Peking Union Medical College, Langfang, Hebei, 065000, China
募集中
Heilongjiang
Harbin Medical University Cancer Hospital, Haerbin, Heilongjiang, 150081, China
募集中
Henan
Henan Cancer Hospital, Zhengzhou, Henan, 450003, China
募集中
The First Affiliated hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
募集中
Hubei
Tongji Hospital, Wuhan, Hubei, 430030, China
募集準備中
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, China
募集中
Hunan
Hunan Cancer Hospital, Changsha, Hunan, 200032, China
募集準備中
Jiangsu
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China
募集中
Jiangsu Cancer Hospital, Nanjing, Jiangsu, 210009, China
募集準備中
Jiangsu Province Hospital, Nanjing, Jiangsu, 210029, China
募集中
The First Affiliate of Soochow University, Suzhou, Jiangsu, 215006, China
募集準備中
Jiangxi
The First Affiliated hospital of Nanchang University, Nanchang, Jiangxi, 330006, China
募集中
Liaoning
The First Hospital of China Medical University, Shenyang, Liaoning, 110001, China
募集中
Shanghai Municipality
Shanghai Jiaotong University School of Medicine Ruijin Hospital, Shanghai, Shanghai Municipality, 200025, China
募集準備中
Fudan University Zhongshan Hospital, Shanghai, Shanghai Municipality, 200032, China
募集準備中
Huashan Hospital Fudan University, Shanghai, Shanghai Municipality, 200040, China
募集準備中
Shanxi
ShanXi Cancer Hospital, Taiyuan, Shanxi, 650118, China
募集中
The First Affiliated hospital of Xi'an Jiaotong University, Xi’an, Shanxi, 710061, China
募集準備中
Sichuan
West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China
募集準備中
Tianjin Municipality
Tianjin Medical University Cancer Institute&Hospital, Tianjin, Tianjin Municipality, 300211, China
募集準備中
Zhejiang
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310005, China
募集中
The Second Affiliate Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China
募集準備中
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, China
募集準備中