Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations
Recruiting · NCT07640295 · Interventional (participants receive a specific treatment) · Lead sponsor: Jacobio Pharmaceuticals Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
JAB-23E73 tablet,nab-paclitaxel,gemcitabine
What this trial is about
The purpose of this study is to determine the safety and efficacy of pan KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in participants with metastatic PDAC harboring KRAS gene alterations.
Who can take part
Age range
18 Years and older
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
- Written informed consent signed by the participant or the participant's legally authorized representative must be obtained prior to performing any study-related procedures. 2. Histologically or cytologically confirmed metastatic PDAC.
- \. No prior systemic antitumor therapy for advanced disease (treatment-naïve). 4. Presence of KRAS gene alterations: be enrolled upon approval by the sponsor).
- \. ECOG performance status score of 0 or 1. 6. Adequate organ function.
Exclusion criteria
- Inability to swallow oral medications or the presence of gastrointestinal dysfunction or disease that may significantly alter drug absorption.
- A history of another malignancy within 2 years prior to the first dose, histologically distinct from the cancer under study, except for carcinoma in situ of the cervix, superficial non-invasive bladder cancer, or adequately treated stage I non-melanoma skin cancer.
- Prior treatment with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-KRAS/pan RAS inhibitors, or other agents of the same class.
- Women who are pregnant or breast-feeding.
- Participants who have progressive disease or recurrence during neoadjuvant or adjuvant treatment, or within 6 months after the last dose of medication.
Where it is running
13 locations listed.
- Beijing Tsinghua Changgung Hospital - Beijing, China
- Hunan Cancer Hospital - Changsha, China
- Harbin Medical University Cancer Hospital - Harbin, China
- Jiangsu Province Hospital - Nanjing, China
- Shanghai Jiaotong University School of Medicine Ruijin Hospital - Shanghai, China
- ShanXi Cancer Hospital - Taiyuan, China
- Hubei Province Hospital - Wuhan, China
- Wuhan Union Hospital Of China - Wuhan, China
- Zhongnan Hospital of Wuhan University - Wuhan, China
- Henan Cancer Hospital - Zhengzhou, China
- The First Affiliated hospital of Zhengzhou University - Zhengzhou, China
- Beijing Cancer Hospital - Beijing, Beijing Municipality, China
- Zhejiang Cancer Hospital - Hangzhou, Zhejiang, China