Phase 1 Study on the Safety and Effectiveness of XER-001 with Radiation Therapy for Locally Advanced Pancreatic Cancer
Sponsor: Xerient Pharma
ClinicalTrials ID:NCT07157033
This clinical trial is testing a new treatment, XER-001, combined with targeted radiation therapy to see if it is safe and effective for patients with locally advanced pancreatic cancer. The study aims to find the best dose for future research.
Patient Parameters
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Program Overview
The study aims to evaluate the safety and effectiveness of a new treatment, XER-001, when given with targeted radiation therapy (SBRT) for patients with locally advanced pancreatic cancer. Researchers want to determine the best dose for future studies and see how well this combination works in controlling the cancer.
Description
This study is divided into two parts. In the first part, researchers will focus on the safety and how well patients tolerate XER-001 when it is delivered directly to the small intestine and combined with targeted radiation therapy (SBRT). In the second part, they will look at how effective this combination is in treating pancreatic cancer, especially when the radiation dose to the small intestine is increased.
Participants will receive XER-001 through a tube that goes from the nose to the small intestine, along with radiation therapy aimed at the tumor. The study will monitor the safety of this approach and how well it works in shrinking or controlling the cancer.
The trial is open to adults with locally advanced pancreatic cancer that cannot be surgically removed. Participants must have completed initial chemotherapy and be in good overall health. They will need to follow specific procedures during the study, such as holding their breath during radiation therapy and using effective birth control if they are of childbearing potential.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of pancreatic cancer.
- Cancer that is locally advanced and cannot be surgically removed, as determined by a specialist team.
- No spread of cancer to distant parts of the body.
- Completed initial chemotherapy treatment.
- Able to follow treatment procedures, such as breath-holding during radiation therapy.
- Age 18 or older.
- Good overall health with a performance status of 0, 1, or 2.
- Adequate blood cell counts and liver function.
- No significant heart rhythm issues on an ECG.
- Willing to comply with study procedures and provide informed consent.
- Women of childbearing potential must use effective birth control during and after the study.
Exclusion Criteria
- Previous radiation therapy to the upper abdomen.
- Previous surgery to remove the pancreatic tumor.
- Active stomach or intestinal ulcers.
- Visible tumor invasion into the bowel or stomach.
- Severe side effects from previous chemotherapy.
- Participation in another interventional clinical trial within 30 days.
- Uncontrolled illnesses, such as heart failure or infections.
- Recent heart attack or unstable chest pain.
- History of low calcium levels or parathyroid issues.
- Severe liver or kidney problems.
- History of certain heart conditions or family history of heart issues.
- Pregnant or breastfeeding women.
- Employees of the study sponsor or site personnel directly involved in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope | 91010 | Duarte | California |
| CIty of Hope | 92618 | Irvine | California |
| Christus St. Vincent Regional Cancer Center | 87505 | Santa Fe | New Mexico |
| Oncology Consultants, P.A. | 77030 | Houston | Texas |
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