Study on JAB-23E73 for Adults with Advanced Solid Tumors with KRAS Alteration
Sponsor: Jacobio Pharmaceuticals Co., Ltd.
ClinicalTrials ID:NCT06973564
This clinical trial is testing a new drug, JAB-23E73, to see if it is safe and well-tolerated in adults with advanced solid tumors that have a specific KRAS gene alteration. The study aims to find the best dose and evaluate the drug's effectiveness.
Patient Parameters
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Program Overview
The purpose of this study is to determine if the new drug JAB-23E73 is safe and can be tolerated by adults with advanced solid tumors that have a KRAS gene alteration. The study will also look at how the drug behaves in the body and its preliminary effects on cancer. It is divided into different phases to find the best dose and to further explore the drug's effectiveness and safety in specific types of tumors, including colorectal cancer, pancreatic cancer, and other solid tumors.
Description
This clinical trial is designed to test a new drug called JAB-23E73 in adults with advanced solid tumors that have a change in the KRAS gene. The study is being conducted at multiple centers and is open-label, meaning both the researchers and participants know what treatment is being given. The trial is divided into several parts:
- Phase 1a: This part will test different doses of JAB-23E73 to find the highest dose that can be given safely.
- Phase 1b: After finding a safe dose, this phase will expand to include more participants to further evaluate the drug's safety and how it works in the body.
- Phase 2a: This phase will focus on specific types of tumors with KRAS alterations, including colorectal cancer, pancreatic cancer, and other solid tumors, to see how effective the drug is.
Participants will receive JAB-23E73 as a single treatment, and researchers will monitor their health and the drug's effects on their cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of advanced or metastatic solid tumors that cannot be cured with standard treatments.
- Have a specific alteration in the KRAS gene.
- Provide a previous tumor sample for analysis.
- Have a life expectancy of at least 3 months.
- Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have at least one measurable tumor that can be tracked using standard criteria.
Exclusion Criteria
- Cannot swallow pills or have digestive issues that affect drug absorption.
- Have been treated with specific KRAS inhibitors before.
- Have a known serious allergy to JAB-23E73 or its ingredients.
- Have primary brain tumors.
- Have uncontrolled fluid buildup around the lungs, heart, or abdomen that requires frequent medical intervention.
- Have a prolonged QT interval on an ECG (greater than 470 milliseconds).
- Have a heart's left ventricle pumping ability of 50% or lower.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic | 55905 | Rochester | Minnesota |
| Washington University | 63110 | Saint Louis | Missouri |
| Cleveland Clinic Foundation | 44195 | Cleveland | Ohio |
| Huntsman Cancer Institute | 84112 | Salt Lake City | Utah |
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