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The goal of this clinical trial is to learn if drug DZ-002 works to treat adults with metastatic pancreatic adenocarcinoma. It will also learn about the safety of drug DZ-002. The main questions it aims to answer are: * To determine the appropriate dose of DZ-002; and * To assess the safety and efficacy of DZ-002. Participants will receive one of three different doses of the study drug through an IV over a 4-hour period on Days 1, 8, 15, and 22 of a 4-week period, or cycle. During the study, participants will have regular visits to the study clinic and multiple tests for safety and research purposes, including blood tests, along with other tests and scans. Participants will receive the study drug weekly in 4-week (28-day cycles) until there are side effects that cannot be tolerated, there is disease-worsening, or the researchers decide to stop. A post-treatment visit and a 30-day post-treatment follow up visit will be conducted after the last dose of study drug. Risks of DZ-002 include nausea, vomiting, diarrhea, chills, low levels of red blood cells, low levels of platelets, fatigue, skin rash, low blood pressure, and feeling unwell.
This is an open label, non-randomized, Phase 2 study to asses the efficacy, safety, PK and pharmacodynamic study of DZ-002 in patients with metastatic pancreatic adenocarcinoma who have completed four or more months of first line chemotherapy with a response of stable disease, partial response, or complete response as documented by CT. There are two parts in this study, a dose escalation part and a dose expansion part. In the dose escalation part of this study, participants will receive one of three different doses of the study drug DZ-002: 5 mg/kg, 6 mg/kg, or 7 mg/kg. Participants will receive the study drug intravenously (into a vein) over a 4-hour period on Days 1, 8, 15, and 22 of a 4-week period. This 4-week period (28 days) is referred to as a cycle. The first 3 to 6 participants taking part in this study will get the lowest dose of 5 mg/kg. If the drug does not cause worrisome side effects, the next group of 3 to 6 participants in the study will get a higher dose of 6 mg/kg. If the drug does not cause worrisome side effects, the last group of 3 to 6 participants will receive the highest dose of 7 mg/kg. The investigator will watch each group carefully as they increase the dose. The dose will increase for each group until participants have worrisome side effects that require the dose to be lower. Once the highest dose with manageable side effects is found, the dose escalation is stopped. In the dose expansion part of this study, the highest dose with manageable side effects will be given to 30 more participants. This will help the investigators better understand the side effects that may happen with this drug. Participation in this study is divided into different visits: 1. Screening Visits 2. Treatment Visits 3. End of Treatment Visits 4. Post-Treatment Visits Various tests are run during each of these different visits as described below: * Collection of medical history and current medications * Physical exam, height, weight, vital signs * Lung function tests * CT scans or PET scans * Heart function tests, such as Echocardiogram or multiple-gated acquisition * Electrocardiograms (ECG) * Blood draws for routine lab tests * Additional blood samples to measure the amount of study drug in blood * Urine collection * X-ray, if indicated * Tumor biopsy, optional * Pregnancy test, if applicable
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Start Date
January 1, 2026
Primary Completion Date
November 1, 2028
Completion Date
April 1, 2029
Last Updated
January 15, 2026
39
ESTIMATED participants
DZ-002 - 5 mg/kg, 6 mg/kg, or 7 mg/kg
DRUG
Lead Sponsor
Hoag Memorial Hospital Presbyterian
Collaborators
NCT05053971
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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