رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT06959615 لـ ورم صلب متقدم هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration المرحلة الأولى, المرحلة الثانية ٣٣٤ تصعيد الجرعة تجربة مفتوحة
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06959615 مصممة لدراسة علاج لـورم صلب متقدم. إنها تجربة تدخُّلية من المرحلة الأولى المرحلة الثانية وهي يقبل مشاركين. بدأت في ٢٠ جمادى الأولى ١٤٤٦ هـ مع خطة لتجنيد ٣٣٤ مشاركًا. تقودها Jacobio Pharmaceuticals Co., Ltd.، ومن المتوقع اكتمالها بحلول ٢٩ ربيع الأول ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١ شعبان ١٤٤٧ هـ.
الملخص
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.
وصف مفصل
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...عرض المزيد
العنوان الرسمي
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
الحالات الطبية
ورم صلب متقدممعرّفات دراسة أخرى
- JAB-23E73-1001
NCT معرّف
تاريخ البدء (فعلي)
2024-11-22
آخر تحديث مُنشور
2026-01-20
تاريخ الاكتمال (المقدر)
2027-08-31
عدد المشاركين المخطط لهم
٣٣٤
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الأولى
المرحلة الثانية
المرحلة الثانية
الحالة
يقبل مشاركين
الكلمات الرئيسية
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
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
غير عشوائي
نموذج التدخل
تصميم تسلسلي
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةPhase 1 Dose Exploration Monotherapy, dose escalation | JAB-23E73 Administered orally |
تجريبيةPhase 2a Dose Expansion Monotherapy, dose expansion | JAB-23E73 Administered orally |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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 |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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 |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
طفل, بالغ, كبار السن
الجنس المؤهل
الكل
- 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.جهة اتصال مركزية للدراسة
جهة اتصال: Jacobio Pharmaceuticals, 86 10 56315466, [email protected]
32 مواقع الدراسة في 1 بلدان
Anhui
Anhui Provincial Cancer Hospital, Hefei, Anhui, 230001, China
لم يبدأ القبول بعد
Beijing Municipality
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing Municipality, 100021, China
يقبل مشاركين
Beijing Cancer Hospital, Beijing, Beijing Municipality, 100032, China
يقبل مشاركين
Beijing Chest Hospital, Beijing, Beijing Municipality, 100032, China
يقبل مشاركين
Peking Union Medical College Hospital, Beijing, Beijing Municipality, 100032, China
يقبل مشاركين
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, 100050, China
لم يبدأ القبول بعد
Fujian
Fujian cancer Hospital, Fuzhou, Fujian, 350014, China
لم يبدأ القبول بعد
Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510120, China
يقبل مشاركين
Guangxi
Guangxi Medical University Cancer Hospital, Nanning, Guangxi, 530012, China
يقبل مشاركين
Hebei
National Cancer Center/Cancer Hospital- Langfang Campus, Chinese Academy of Medical Sciences and Peking Union Medical College, Langfang, Hebei, 065000, China
يقبل مشاركين
Heilongjiang
Harbin Medical University Cancer Hospital, Haerbin, Heilongjiang, 150081, China
يقبل مشاركين
Henan
Henan Cancer Hospital, Zhengzhou, Henan, 450003, China
يقبل مشاركين
The First Affiliated hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
يقبل مشاركين
Hubei
Tongji Hospital, Wuhan, Hubei, 430030, China
لم يبدأ القبول بعد
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, China
يقبل مشاركين
Hunan
Hunan Cancer Hospital, Changsha, Hunan, 200032, China
لم يبدأ القبول بعد
Jiangsu
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China
يقبل مشاركين
Jiangsu Cancer Hospital, Nanjing, Jiangsu, 210009, China
لم يبدأ القبول بعد
Jiangsu Province Hospital, Nanjing, Jiangsu, 210029, China
يقبل مشاركين
The First Affiliate of Soochow University, Suzhou, Jiangsu, 215006, China
لم يبدأ القبول بعد
Jiangxi
The First Affiliated hospital of Nanchang University, Nanchang, Jiangxi, 330006, China
يقبل مشاركين
Liaoning
The First Hospital of China Medical University, Shenyang, Liaoning, 110001, China
يقبل مشاركين
Shanghai Municipality
Shanghai Jiaotong University School of Medicine Ruijin Hospital, Shanghai, Shanghai Municipality, 200025, China
لم يبدأ القبول بعد
Fudan University Zhongshan Hospital, Shanghai, Shanghai Municipality, 200032, China
لم يبدأ القبول بعد
Huashan Hospital Fudan University, Shanghai, Shanghai Municipality, 200040, China
لم يبدأ القبول بعد
Shanxi
ShanXi Cancer Hospital, Taiyuan, Shanxi, 650118, China
يقبل مشاركين
The First Affiliated hospital of Xi'an Jiaotong University, Xi’an, Shanxi, 710061, China
لم يبدأ القبول بعد
Sichuan
West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China
لم يبدأ القبول بعد
Tianjin Municipality
Tianjin Medical University Cancer Institute&Hospital, Tianjin, Tianjin Municipality, 300211, China
لم يبدأ القبول بعد
Zhejiang
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310005, China
يقبل مشاركين
The Second Affiliate Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China
لم يبدأ القبول بعد
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, China
لم يبدأ القبول بعد