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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
Phase
Phase 1/2
Started
2026-07-16
Last updated
2026-08-27

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

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)

FacilityCityRegionStatus
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
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