Oncolytic Virus Therapy for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to see if LOAd703 (an oncolytic adenovirus) can be safely given to patients with pancreatic cancer. The study will also evaluate whether or not intratumoral injection of LOAd703 will support current standard of care treatment to reduce the size of the tumor and improve survival of the patients.Adenoviruses are known as the "common cold" virus and most individuals have had multiple infections during their lifetime. Oncolytic adenoviruses are adenoviruses that are modified so they cannot multiply and spread (known as replicating) properly in normal (e.g. healthy) cells, but instead, they infect and replicate very well in cancer cells. This strong replication leads to the death of the cancer cell. Oncolytic viruses have been evaluated in multiple clinical trials for cancer treatment during the past decade and been proven safe. It is common to have a fever the first day or two after virus injection since the immune system will react to the virus infection. The immune system can also kill cancer cells but to do so it needs to be properly stimulated. Oncolytic viruses alone do not seem to be strong enough to activate clinically relevant anti-cancer responses. However, it is thought that if additional immune system stimulators are added to the oncolytic viruses they may be able to result in clinical relevant antic-cancer responses.LOAd703 is an oncolytic adenovirus that has been modified to include additional immune system stimulators. Specifically, genes that stimulate the immune system have been added to the oncolytic adenovirus. Once the oncolytic adenovirus infects the cancer cells, the genes will be expressed, resulting in activation of the immune response so it can attack and kill cancer cells.In this study, LOAd703 will be given by intratumoral injections. It will be given in addition to standard of care treatment with gemcitabine and nab-paclitaxel +/- the anti-PD-L1 antibody atezolizumab. Because this is an experimental therapy, there will be extra visits for disease monitoring and samples accordingly to the detailed information below. The LOAd703 is an investigational agent not approved by the FDA.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop all current medications. However, you cannot take high-dose corticosteroids, certain immune inhibitors, biologic therapies, investigational agents, or systemic immunostimulatory agents close to or during the trial. Check with the trial team about your specific medications.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but certain treatments like high-dose corticosteroids, immune inhibitors, and investigational agents are not allowed close to the start of the study. It's best to discuss your specific medications with the trial team.
What safety data exists for Oncolytic Virus Therapy for Pancreatic Cancer?
The provided research does not contain specific safety data for Oncolytic Virus Therapy, including LOAd703 or Delolimogene Mupadenorepvec, for pancreatic cancer. The studies mentioned focus on other treatments like Rexin-G, FG-3019, ASG-5ME, and nanoliposomal irinotecan, which have been evaluated for safety in pancreatic cancer patients. For specific safety data on Oncolytic Virus Therapy, further research or clinical trial results would be needed.12345
Is the treatment LOAd703 a promising treatment for pancreatic cancer?
Yes, LOAd703 is a promising treatment for pancreatic cancer because oncolytic virus therapy, like LOAd703, can specifically target and destroy cancer cells while also boosting the body's immune response against the tumor. This approach offers hope for improving outcomes in a cancer type that is usually very hard to treat.678910
How is the treatment LOAd703 different from other treatments for pancreatic cancer?
LOAd703 is an oncolytic virus therapy that specifically targets and destroys cancer cells while also boosting the body's immune response against the tumor, offering a novel approach compared to traditional treatments like chemotherapy, which often have limited effectiveness in pancreatic cancer.678910
What data supports the idea that Oncolytic Virus Therapy for Pancreatic Cancer is an effective treatment?
The available research shows that Oncolytic Virus Therapy is a promising treatment for pancreatic cancer. It specifically targets and destroys cancer cells while also boosting the body's immune response against the tumor. Although traditional treatments like chemotherapy have not significantly improved survival rates, Oncolytic Virus Therapy offers a new approach by overcoming the challenges posed by the tumor's environment. Studies have shown encouraging results in both lab and early human trials, suggesting it could be more effective than existing treatments.7891112
What data supports the effectiveness of the treatment LOAd703, Delolimogene Mupadenorepvec, for pancreatic cancer?
Research suggests that oncolytic viral therapy, which includes treatments like LOAd703, shows promise for pancreatic cancer by specifically targeting and destroying cancer cells and boosting the body's immune response against the tumor. Although challenges exist, such as the tumor's protective environment, these therapies are being explored in clinical trials to improve outcomes for this aggressive cancer.7891112
Who Is on the Research Team?
Angelica Loskog, PhD
Principal Investigator
Lokon Pharma AB
Are You a Good Fit for This Trial?
Adults diagnosed with pancreatic ductal adenocarcinoma, not eligible for surgery, can join this trial. They must be fit for standard chemotherapy and able to undergo sedation for injections. Women of childbearing age need a negative pregnancy test and must use contraception. Exclusions include pregnant or breastfeeding women, recent biologic therapy users, those with certain illnesses or high-dose steroid treatment, and individuals with other cancers within the last two years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care treatment with gemcitabine and nab-paclitaxel, and intratumoral injections of LOAd703 every other week for 6 doses, with an option for 6 additional doses if beneficial.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with blood samples and imaging to evaluate tumor size and health status.
Extension
Participants may receive up to 6 additional doses of LOAd703 if they are benefiting from the treatment.
What Are the Treatments Tested in This Trial?
Interventions
- LOAd703
LOAd703 is already approved in United States for the following indications:
- None approved yet; received FDA Fast Track designation for pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lokon Pharma AB
Lead Sponsor