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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Male or female patients ≥18 years of age;
✓. Measurable or evaluable disease by RECIST v 1.1;
✓. Capable of understanding and complying with protocol requirements;
✓. A life expectancy of greater than 8 weeks at Screening;
✓. ECOG PS of 0 to 1;
✓. Written informed consent from the patient or the patient's legally acceptable representative prior to the initiation of any study procedures;
✓. Adequate bone marrow, liver, and renal function as defined below:
Exclusion criteria
✕. New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, a history of risk factors for Torsades de Points, including heart failure, hypokalemia, and family history of long QTc syndrome, or evidence of ischemia on ECG;
What they're measuring
1
Recommended Phase 2 Dose (RP2D)
Timeframe: Up to 28 days of last patient dosed during the escalation phase
✕. Baseline QTc exceeding 470 msec (using the Fridericia's formula) and/or patients receiving Class 1A or Class III antiarrhythmic agents or concomitant medications that prolong the QT/QTc interval;
✕. Patients with individual pulmonary metastases \> 5 cm diameter or with high metastatic burden to the lungs as determined by the principal or the primary investigator;
✕. Patients with extensive bone metastases as determined by the principal or the primary investigator;
✕. Patients with a current positive COVID-19 diagnosis, or are currently symptomatic with COVID-19, or who have had COVID-19 in the last month, or with a history of COVID-19 diagnosis with respiratory complications;
✕. Treatment with simvastatin unless it can be stopped prior to and during the study;
✕. Treatment with strong inhibitors and inducers of CYP3A4 or narrow therapeutic index substrates of CY3A4, CYP2B6, CYP1A2, CYP2C9, and CYP2C8, unless these can be stopped prior to and during the study;