Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations

Summary

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.

Interventions

• JAB-23E73 tablet，nab-paclitaxel，gemcitabine · DRUG

  Orally, intravenous (IV) infusion

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

1.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.

3\. No prior systemic antitumor therapy for advanced disease (treatment-naïve). 4. Presence of KRAS gene alterations: be enrolled upon approval by the sponsor).

5\. ECOG performance status score of 0 or 1. 6. Adequate organ function.

Exclusion Criteria:

1. Inability to swallow oral medications or the presence of gastrointestinal dysfunction or disease that may significantly alter drug absorption.
2. 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.
3. Prior treatment with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-KRAS inhibitors, or other agents of the same class.
4. Primary central nervous system (CNS) tumors.
5. Women who are pregnant or breast-feeding.
6. Participants who have progressive disease or recurrence during neoadjuvant or adjuvant treatment, or within 6 months after the last dose of medication.

Sites (13)

• Beijing Cancer Hospital, Beijing, Beijing Municipality, China
• Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
• 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