Study on DZ-002 Maintenance Therapy for Metastatic Pancreatic Cancer
Sponsor: Hoag Memorial Hospital Presbyterian
ClinicalTrials ID:NCT07344220
This clinical trial is testing a new drug, DZ-002, to see if it can help treat adults with metastatic pancreatic cancer. The study will also check the safety of DZ-002 and find the best dose to use.
Patient Parameters
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Program Overview
The purpose of this study is to find out if the drug DZ-002 can help treat adults with metastatic pancreatic cancer and to learn about its safety. Participants will receive one of three different doses of DZ-002 through an IV over a 4-hour period on specific days of a 4-week cycle. The study will continue until participants experience side effects that cannot be tolerated, the cancer worsens, or the researchers decide to stop. Participants will have regular clinic visits and tests, including blood tests and scans, to monitor their health and the effects of the drug. After the treatment ends, there will be follow-up visits to check on participants' health. Possible side effects of DZ-002 include nausea, vomiting, diarrhea, chills, low blood cell counts, fatigue, skin rash, low blood pressure, and feeling unwell.
Description
This study is open to adults with metastatic pancreatic cancer who have completed at least four months of initial chemotherapy and have stable disease or better. The study has two parts: dose escalation and dose expansion. In the dose escalation part, participants will receive one of three doses of DZ-002 (5 mg/kg, 6 mg/kg, or 7 mg/kg) through an IV on specific days of a 4-week cycle. The dose will increase for each group until side effects become too severe. In the dose expansion part, the highest dose with manageable side effects will be given to more participants to better understand the drug's effects. Participants will have different visits, including screening, treatment, end of treatment, and post-treatment visits. During these visits, various tests will be conducted, such as medical history collection, physical exams, scans, heart and lung function tests, blood and urine tests, and optional tumor biopsies. Women who can become pregnant will have a pregnancy test.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with metastatic pancreatic cancer and completed at least 4 months of initial chemotherapy with stable disease or better.
- Aged 18 years or older.
- Have measurable or evaluable cancer.
- Able to understand and follow study requirements.
- Expected to live more than 8 weeks.
- In good overall health with an ECOG performance status of 0 or 1.
- Provide written informed consent.
- Have adequate bone marrow, liver, and kidney function as shown by specific blood tests.
- Have good heart function with a left ventricular ejection fraction over 50%.
- Have good lung function with specific test results.
Exclusion Criteria
- Severe heart disease or recent heart attack.
- Abnormal heart rhythm or medications affecting heart rhythm.
- Large lung tumors or many lung metastases.
- Extensive bone metastases.
- Current or recent COVID-19 infection.
- Active infections needing treatment.
- Taking certain medications that cannot be stopped.
- Allergic to DZ-002 or its ingredients.
- Pregnant or breastfeeding.
- Unable to follow study procedures.
- HIV with low CD4 count, active hepatitis B or C.
- Serious non-cancerous diseases affecting study participation.
- Currently in another clinical trial.
- Certain genetic conditions or taking specific medications like nitroglycerine or antimalarials.
- Known lung disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | 92663 | Newport Beach | California |
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