Hoag Memorial Hospital Presbyterian
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 rece…
Inclusion Criteria: 1. Histopathologically confirmed diagnosis of metastatic pancreatic adenocarcinoma who completed 4 months or more of first line chemotherapy and have achieved at least SD documented by CT scan. 2. Male or female patients ≥18 years of age; 3. Measurable or evaluable disease by RECIST v 1.1; 4. Capable of understanding and complying with protocol requirements; 5. A life expectancy of greater than 8 weeks at Screening; 6. ECOG PS of 0 to 1; 7. Written informed consent from the patient or the patient's legally acceptable representative prior to the initiation of any study proc…
5 mg/kg, 6 mg/kg, or 7 mg/kg DZ-002 administered by IV over a 4-hour period, on Days 1, 8, 15, and 22 of a 4-week period, or cycle.