A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration
Recruiting · NCT06959615 · Interventional (participants receive a specific treatment) · Lead sponsor: Jacobio Pharmaceuticals Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
JAB-23E73
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
60 locations listed.
- Anhui Provincial Cancer Hospital - Hefei, Anhui, China
- Anhui Provincial Cancer Hospital - Hefei, Anhui, China
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College - Beijing, Beijing Municipality, China
- Beijing Cancer Hospital - Beijing, Beijing Municipality, China
- Beijing Chest Hospital - Beijing, Beijing Municipality, China
- Peking Union Medical College Hospital - Beijing, Beijing Municipality, China
- Beijing Friendship Hospital, Capital Medical University - Beijing, Beijing Municipality, China
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College - Beijing, Beijing Municipality, China
- Beijing Cancer Hospital - Beijing, Beijing Municipality, China
- Beijing Chest Hospital - Beijing, Beijing Municipality, China
- Peking Union Medical College Hospital - Beijing, Beijing Municipality, China
- Beijing Friendship Hospital, Capital Medical University - Beijing, Beijing Municipality, China
- Fujian cancer Hospital - Fuzhou, Fujian, China
- Fujian cancer Hospital - Fuzhou, Fujian, China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Guangzhou, Guangdong, China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Guangzhou, Guangdong, China
- Guangxi Medical University Cancer Hospital - Nanning, Guangxi, China
- Guangxi Medical University Cancer Hospital - Nanning, Guangxi, China
- National Cancer Center/Cancer Hospital- Langfang Campus, Chinese Academy of Medical Sciences and Peking Union Medical College - Langfang, Hebei, China
- National Cancer Center/Cancer Hospital- Langfang Campus, Chinese Academy of Medical Sciences and Peking Union Medical College - Langfang, Hebei, China
- Harbin Medical University Cancer Hospital - Haerbin, Heilongjiang, China
- Harbin Medical University Cancer Hospital - Haerbin, Heilongjiang, China
- Henan Cancer Hospital - Zhengzhou, Henan, China
- The First Affiliated hospital of Zhengzhou University - Zhengzhou, Henan, China
- Henan Cancer Hospital - Zhengzhou, Henan, China
- The First Affiliated hospital of Zhengzhou University - Zhengzhou, Henan, China
- Tongji Hospital - Wuhan, Hubei, China
- Zhongnan Hospital of Wuhan University - Wuhan, Hubei, China
- Tongji Hospital - Wuhan, Hubei, China
- Zhongnan Hospital of Wuhan University - Wuhan, Hubei, China
- Hunan Cancer Hospital - Changsha, Hunan, China
- Hunan Cancer Hospital - Changsha, Hunan, China
- Nanjing Drum Tower Hospital - Nanjing, Jiangsu, China
- Jiangsu Cancer Hospital - Nanjing, Jiangsu, China
- Jiangsu Province Hospital - Nanjing, Jiangsu, China
- Nanjing Drum Tower Hospital - Nanjing, Jiangsu, China
- Jiangsu Cancer Hospital - Nanjing, Jiangsu, China
- Jiangsu Province Hospital - Nanjing, Jiangsu, China
- The First Affiliate of Soochow University - Suzhou, Jiangsu, China
- The First Affiliate of Soochow University - Suzhou, Jiangsu, China
- The First Affiliated hospital of Nanchang University - Nanchang, Jiangxi, China
- The First Affiliated hospital of Nanchang University - Nanchang, Jiangxi, China
- The First Hospital of China Medical University - Shenyang, Liaoning, China
- The First Hospital of China Medical University - Shenyang, Liaoning, China
- Shanghai Jiaotong University School of Medicine Ruijin Hospital - Shanghai, Shanghai Municipality, China
- Fudan University Zhongshan Hospital - Shanghai, Shanghai Municipality, China
- Huashan Hospital Fudan University - Shanghai, Shanghai Municipality, China
- Shanghai Jiaotong University School of Medicine Ruijin Hospital - Shanghai, Shanghai Municipality, China
- Fudan University Zhongshan Hospital - Shanghai, Shanghai Municipality, China
- Huashan Hospital Fudan University - Shanghai, Shanghai Municipality, China
- ShanXi Cancer Hospital - Taiyuan, Shanxi, China
- ShanXi Cancer Hospital - Taiyuan, Shanxi, China
- The First Affiliated hospital of Xi'an Jiaotong University - Xi’an, Shanxi, China
- The First Affiliated hospital of Xi'an Jiaotong University - Xi’an, Shanxi, China
- West China Hospital, Sichuan University - Chengdu, Sichuan, China
- West China Hospital, Sichuan University - Chengdu, Sichuan, China
- Tianjin Medical University Cancer Institute&Hospital - Tianjin, Tianjin Municipality, China
- Tianjin Medical University Cancer Institute&Hospital - Tianjin, Tianjin Municipality, China
- Zhejiang Cancer Hospital - Hangzhou, Zhejiang, China
- The Second Affiliate Hospital Zhejiang University School of Medicine - Hangzhou, Zhejiang, China
Showing 60 of 64 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →