DZ-002 for Pancreatic Cancer
(DZ-002-201 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Carlos Becerra, MD
Principal Investigator
Hoag Memorial Hospital Presbyterian
Are You a Good Fit for This Trial?
Adults with metastatic pancreatic adenocarcinoma who've had at least 4 months of first-line chemo and stable disease shown by CT scan. They must be over 18, understand the study, have a life expectancy over 8 weeks, an ECOG performance status of 0-1, and adequate blood counts.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive one of three different doses of DZ-002 intravenously over a 4-hour period on Days 1, 8, 15, and 22 of a 4-week cycle. The dose is increased until worrisome side effects are observed.
Dose Expansion
Participants receive the highest dose with manageable side effects determined from the dose escalation phase. This phase helps to better understand the side effects of DZ-002.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a post-treatment visit and a 30-day post-treatment follow-up visit.
What Are the Treatments Tested in This Trial?
Interventions
- DZ-002
Trial Overview
The trial tests DZ-002's effectiveness in treating metastatic pancreatic cancer. Participants will receive one of three doses via IV on specific days across a 28-day cycle. The treatment continues unless side effects are intolerable or the disease worsens.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Additional 30 patients will be enrolled and receive the RP2D from the dose escalation phase. All patients will receive the iv weekly selected RP2Dose from dose escalation portion.
First 9-18 patients will be enrolled on the dose escalation portion. Starting dose: 3-6 study participants 5 mg/kg iv weekly Second dose: 3-6 study participants 6 mg/kg iv weekly Final dose: 3-6 study participants 7 mg/kg iv weekly
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoag Memorial Hospital Presbyterian
Lead Sponsor
Da Zen Theranostics Inc
Industry Sponsor
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