DZ-002 for Pancreatic Cancer
(DZ-002-201 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, DZ-002, to determine its potential in treating metastatic pancreatic adenocarcinoma, an advanced form of pancreatic cancer. The trial aims to identify the appropriate dose and assess the drug's safety and effectiveness. Participants will receive DZ-002 through an IV once a week in 4-week cycles. Eligible participants must have completed at least four months of first-line chemotherapy for this cancer and have stable disease as shown by a CT scan. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
You may need to stop taking certain medications before and during the study, especially if you are on simvastatin or medications that affect specific liver enzymes. It's best to discuss your current medications with the study team to see if any changes are needed.
Is there any evidence suggesting that DZ-002 is likely to be safe for humans?
Research shows that DZ-002 undergoes careful monitoring for safety and effectiveness in cancer treatment. In earlier studies, patients experienced side effects like nausea, vomiting, and tiredness, which are common with this treatment. Doctors monitor these effects in current trials to better understand how well people can handle the drug.
DZ-002 is now in Phase 2 trials, indicating some confidence in its safety. Phase 2 trials test the treatment on a larger group after earlier studies suggested it might be safe. This suggests researchers have already seen evidence that the drug could be safe enough for broader testing.
In summary, while DZ-002 has shown some side effects, researchers closely monitor its safety. Progressing to Phase 2 trials indicates some belief in its potential safety and effectiveness for treating cancer.12345Why do researchers think this study treatment might be promising for pancreatic cancer?
Unlike the standard treatments for pancreatic cancer, which usually involve chemotherapy and radiation, DZ-002 is unique because it uses a novel dosing strategy aimed at optimizing effectiveness and minimizing side effects. This investigational drug is administered intravenously in a dose-escalation manner to find the most effective and safest dose, making it distinct from the one-size-fits-all approach of traditional treatments. Researchers are excited about DZ-002 because it targets pancreatic cancer with a precision that could result in better outcomes and improved quality of life for patients.
What evidence suggests that DZ-002 might be an effective treatment for pancreatic cancer?
Research shows that DZ-002 is under study as a potential treatment for metastatic pancreatic adenocarcinoma, a type of pancreatic cancer. Early results suggest that DZ-002 might slow the disease's progression and prolong stability. This drug targets and kills cancer cells, potentially slowing tumor growth. While data collection on its efficacy in humans continues, experts remain hopeful about its potential benefits. As trials progress, more information will emerge about DZ-002's effectiveness in treating this challenging condition.12467
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
Citations
Breakthrough Cancer Therapy Moves to Phase 2 Trials
“My greatest hope for DZ-002 is that it brings new possibilities to cancer treatment and helps save patients' lives,” Henary says. “It has shown ...
2.
trial.medpath.com
trial.medpath.com/news/267332acf7803969/dz-002-cancer-therapy-advances-to-phase-2-trials-for-pancreatic-cancer-treatmentDZ-002 Cancer Therapy Advances to Phase 2 Trials for ...
Phase 2 trials will evaluate safety, dosage parameters, and therapeutic efficacy in pancreatic cancer patients at HOAG Cancer Center, focusing on extending ...
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