Clinical Trials in China / NCT07640295
Recruiting
Phase 1/2
Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations
NCT07640295 · tracked via the Priya Life Science China tracker
Condition(s) studied
Metastatic Pancreatic Ductal Adenocarcinoma
Investigational drug(s) / intervention(s)
JAB-23E73 tablet,nab-paclitaxel,gemcitabine
JAB-23E73 tablet,nab-paclitaxel,gemcitabine: Orally, intravenous (IV) infusion
Study 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.
Eligibility
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 |
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Official registry record
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.
View NCT07640295 on ClinicalTrials.gov ↗ ← All trials in China