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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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/pan RAS inhibitors, or other agents of the same class.
4. Women who are pregnant or breast-feeding.
5. Participants who have progressive disease or recurrence during neoadjuvant or adjuvant treatment, or within 6 months after the last dose of medication.
Primary outcome measure(s)
Dose limiting toxicities (DLT) — Up to 28 days The number and proportion of participants who experienced dose-limiting toxicities (DLT).
Adverse events.safety evaluation — Up to approximately 3 years The types, incidence, severity, and outcomes of adverse events and serious adverse events evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Trial sites (13)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
Beijing Municipality
Recruiting
Zhejiang Cancer Hospital
Hangzhou
Zhejiang
Not Yet Recruiting
Beijing Tsinghua Changgung Hospital
Beijing
China
Recruiting
Hunan Cancer Hospital
Changsha
China
Not Yet Recruiting
Harbin Medical University Cancer Hospital
Harbin
China
Not Yet Recruiting
Jiangsu Province Hospital
Nanjing
China
Not Yet Recruiting
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai
China
Recruiting
ShanXi Cancer Hospital
Taiyuan
China
Recruiting
Hubei Province Hospital
Wuhan
China
Not Yet Recruiting
Wuhan Union Hospital Of China
Wuhan
China
Recruiting
Zhongnan Hospital of Wuhan University
Wuhan
China
Recruiting
Henan Cancer Hospital
Zhengzhou
China
Not Yet Recruiting
The First Affiliated hospital of Zhengzhou University
Zhengzhou
China
Not Yet Recruiting
More Jacobio Pharmaceuticals Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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