Pan-KRAS inhibitor JAB-23E73 with chemotherapy for metastatic pancreatic cancer with KRAS changes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase Ib/III multicenter study to evaluate safety, dosing, pharmacokinetics, and preliminary activity of JAB-23E73 combined with nab-paclitaxel and gemcitabine in treatment-naïve metastatic PDAC with KRAS alterations. The trial starts with dose-escalation to identify a recommended phase III dose, then proceeds to a phase III comparison of JAB-23E73 plus AG versus AG alone. Participants will be adults with good performance status and confirmed metastatic disease, and ongoing safety and preliminary efficacy data will guide progression to the Phase III stage. It is sponsored by Jacobio Pharmaceuticals and conducted at select centers in China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Tsinghua Changgung Hospital
  Beijing, China Recruiting
• Shanghai Jiaotong University School of Medicine Ruijin Hospital
  Shanghai, China Recruiting
• ShanXi Cancer Hospital
  Taiyuan, China Recruiting
• Wuhan Union Hospital Of China
  Wuhan, China Recruiting
• Zhongnan Hospital of Wuhan University
  Wuhan, China Recruiting

Study contacts

• Study coordinator: Jacobio Pharmaceuticals
• Email: clinicaltrials@jacobiopharma.com
• Phone: 86 10 56315466

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.