51 Participants Needed

Oncolytic Virus Therapy for Pancreatic Cancer

Recruiting at 1 trial location
BM
Overseen ByBenjamin Musher, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Lokon Pharma AB
Must be taking: Gemcitabine, Nab-paclitaxel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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 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.12345

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.12345

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.678910

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.2341112

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.2341112

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.

Research Team

AL

Angelica Loskog, PhD

Principal Investigator

Lokon Pharma AB

Eligibility Criteria

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

I am eligible for treatment with gemcitabine and nab-paclitaxel.
My cancer cannot be completely removed by surgery.
I am not pregnant and agree to use birth control during the study.
See 8 more

Exclusion Criteria

I am not on any treatments that could interfere with the study, such as high dose steroids or certain immune system targeting drugs.
I haven't taken strong immune system drugs like alemtuzumab or rapamycin in the last 3 weeks.
I have a noticeable amount of fluid in my abdomen.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

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.

9 months
Biweekly visits for LOAd703 injections, additional visits for standard chemotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment, with blood samples and imaging to evaluate tumor size and health status.

3 months
Every 3 months

Extension

Participants may receive up to 6 additional doses of LOAd703 if they are benefiting from the treatment.

3 months

Treatment Details

Interventions

  • LOAd703
Trial Overview The trial is testing LOAd703, an oncolytic virus modified to boost the immune system against cancer cells when injected into tumors. It's given alongside standard chemo drugs gemcitabine and nab-paclitaxel, with or without atezolizumab (an anti-cancer antibody). The goal is to shrink tumors and improve survival in pancreatic cancer patients.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm 2: Intratumoral LOAd703 + atezolizumabExperimental Treatment4 Interventions
Patients will receive gemcitabine intravenously at a dose of 1000mg/m2 + nab-paclitaxel 125 mg/m2 as per hospital standards. One cycle will be one dose of gemcitabine +nab-paclitaxel given on days 1, 8, and 15 of a 28 day cycle. LOAd703 will be given every other week for 6 doses starting on day 15 of the first cycle of chemotherapy. There is an option for an additional 6 doses if patients benefit from treatment. A fixed dose of atezolizumab 1680 mg will be given every 4 weeks on day 1 of each chemotherapy cycle. Patients will be assigned to the following LOAd703 doses: Dose level 1: 1 X 10\^11 viral particles per treatment Dose level 2: 5 X 10\^11 viral particles per treatment
Group II: Arm 1 Intratumoral LOAd703Experimental Treatment3 Interventions
Patients will receive gemcitabine intravenously at a dose of 1000mg/m2 + nab-paclitaxel 125 mg/m2 as per hospital standards. One cycle will be one dose of gemcitabine +nab-paclitaxel given on days 1, 8, and 15 of a 28 day cycle. LOAd703 will be given every other week for 6 doses starting on day 15 of the first cycle of chemotherapy. There is an option for an additional 6 doses if patients benefit from treatment. The following LOAd703 doses will be evaluated: Dose level 1: 5 X 10\^10 viral particles per treatment Dose level 2: 1 X 10\^11 viral particles per treatment Dose level 3: 5 X 10\^11 viral particles per treatment

LOAd703 is already approved in United States for the following indications:

🇺🇸
Approved in United States as LOAd703 for:
  • 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

Trials
3
Recruited
120+

Findings from Research

Recent studies highlight that pancreatic adenocarcinoma, known for its aggressive nature and poor prognosis, may benefit from immunotherapeutic and oncolytic viral strategies that enhance the immune response against tumors.
Preclinical and early clinical results show promising antitumor efficacy for these novel therapies, suggesting they could improve treatment outcomes and deepen our understanding of pancreatic cancer biology.
Immunotherapeutic and oncolytic viral therapeutic strategies in pancreatic cancer.Khan, ML., Halfdanarson, TR., Borad, MJ.[2023]
Oncolytic virotherapy shows promise as a potential treatment for pancreatic ductal adenocarcinoma (PDAC), a highly aggressive cancer, by specifically targeting and destroying tumor cells while also stimulating the immune response.
The pancreatic tumor microenvironment presents significant challenges for treatment, including immunosuppression and limited drug access, making oncolytic viruses particularly suitable for combination therapies aimed at overcoming these barriers.
Oncolytic virotherapy for pancreatic ductal adenocarcinoma: A glimmer of hope after years of disappointment?Tassone, E., Muscolini, M., van Montfoort, N., et al.[2021]
Oncolytic viruses (OVs) like adenoviruses, herpesviruses, and reoviruses have been extensively studied and are currently in clinical trials as potential treatments for pancreatic cancer, showing promise in targeting this difficult-to-treat disease.
The review highlights the unique biological characteristics of these viruses and suggests that genetic manipulation or combination with other therapies could enhance their effectiveness against pancreatic cancer, leveraging insights from recent studies on the disease's molecular biology.
Oncolytic virotherapy for pancreatic cancer.Wennier, S., Li, S., McFadden, G.[2022]

References

Immunotherapeutic and oncolytic viral therapeutic strategies in pancreatic cancer. [2023]
Oncolytic virotherapy for pancreatic ductal adenocarcinoma: A glimmer of hope after years of disappointment? [2021]
Oncolytic virotherapy for pancreatic cancer. [2022]
Improvement of gemcitabine-based therapy of pancreatic carcinoma by means of oncolytic parvovirus H-1PV. [2022]
Oncolytic viral therapy for pancreatic cancer: current research and future directions. [2020]
First clinical experience using a 'pathotropic' injectable retroviral vector (Rexin-G) as intervention for stage IV pancreatic cancer. [2022]
Novel agents in the management of pancreatic adenocarcinoma: phase I studies. Highlights from the "2011 ASCO Gastrointestinal Cancers Symposium". San Francisco, CA, USA. January 20-22, 2011. [2022]
Novel agents in the treatment of pancreatic adenocarcinoma. [2020]
Update on the role of nanoliposomal irinotecan in the treatment of metastatic pancreatic cancer. [2020]
Folfox4 as a rescue chemotherapy for gemcitabine-refractory pancreatic cancer. [2022]
The potential of oncolytic virus therapy for pancreatic cancer. [2022]
Myxoma Virus Expressing LIGHT (TNFSF14) Pre-Loaded into Adipose-Derived Mesenchymal Stem Cells Is Effective Treatment for Murine Pancreatic Adenocarcinoma. [2023]
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