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NCT06959615

A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration

Traducción pendiente · disponible pronto
Reclutando Fase 1

Descripción

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.

Criterios de Elegibilidad

Inclusion Criteria:

1. 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).

2. Able to provide an archived tumor tissue sample or fresh biopsy sample.

3. Life expectancy ≥3 months at the start of treatment.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

5. ≥1 measurable lesion per RECIST v1.1.

6. Adequate organ function.

Exclusion Criteria:

1. Unable to swallow oral medications or with gastrointestinal dysfunction or gastrointestinal disease that significantly alters the absorption of medication.

2. Previous treatment with rat sarcoma (RAS) targeting agents.

3. Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.

4. Impaired cardiovascular function or clinically significant cardiac disease.

5. Mean QT interval corrected using Fridericia's formula (QTcF) \>470 msec.

6. Females who are pregnant or breastfeeding.

Información del Ensayo

NCT06959615
Reclutando
Fase 1
334 participantes
Nov 2024
Dic 2026

Ubicaciones32

China (32)
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230001 Aún no recluta
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100032 Reclutando
Beijing Chest Hospital
Beijing, Beijing Municipality, 100032 Reclutando
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050 Aún no recluta
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021 Reclutando
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032 Reclutando
Fujian cancer Hospital
Fuzhou, Fujian, 350014 Aún no recluta
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120 Reclutando
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530012 Reclutando
National Cancer Center/Cancer Hospital- Langfang Campus, Chinese Academy of Medical Sciences and Peking Union Medical College
Langfang, Hebei, 065000 Reclutando
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, 150081 Reclutando
Henan Cancer Hospital
Zhengzhou, Henan, 450003 Reclutando
The First Affiliated hospital of Zhengzhou University
Zhengzhou, Henan, 450052 Reclutando
Tongji Hospital
Wuhan, Hubei, 430030 Aún no recluta
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071 Reclutando
Hunan Cancer Hospital
Changsha, Hunan, 200032 Aún no recluta
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009 Aún no recluta
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029 Reclutando
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008 Reclutando
The First Affiliate of Soochow University
Suzhou, Jiangsu, 215006 Aún no recluta
The First Affiliated hospital of Nanchang University
Nanchang, Jiangxi, 330006 Reclutando
The First Hospital of China Medical University
Shenyang, Liaoning, 110001 Reclutando
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032 Aún no recluta
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040 Aún no recluta
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, 200025 Aún no recluta
ShanXi Cancer Hospital
Taiyuan, Shanxi, 650118 Reclutando
The First Affiliated hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061 Aún no recluta
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041 Aún no recluta
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, 300211 Aún no recluta
The Second Affiliate Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009 Aún no recluta
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005 Reclutando
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014 Aún no recluta

Fuente Oficial

Ver en ClinicalTrials.gov