Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Hoag Memorial Hospital Presbyterian
With
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–any
Sex
ALL
Healthy volunteers
Not accepted
