Oncolytic Virus Therapy for Pancreatic Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for pancreatic cancer using a virus called LOAd703 (also known as Delolimogene Mupadenorepvec), designed to attack and kill cancer cells. The goal is to determine if this virus can be safely used alongside standard cancer treatments to shrink tumors and improve survival. Patients with pancreatic cancer who have tumors accessible for injections and are not eligible for full surgical removal may qualify for this trial. Participants will receive regular care with added injections of LOAd703, and some will also receive atezolizumab, a drug that helps the immune system fight cancer. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LOAd703, a special virus designed to attack cancer cells, has been generally safe in past studies. This virus targets and kills only cancer cells, sparing healthy ones. In these studies, researchers used LOAd703 with standard chemotherapy for patients with pancreatic cancer. The results indicated that it was well-tolerated, with most patients not experiencing severe side effects. Some patients might develop a fever shortly after the virus is injected, a common reaction as the body responds to the treatment.

When combined with another drug called atezolizumab, LOAd703 was also well-tolerated. Some patients even experienced a period where their cancer stopped growing. These findings suggest that the treatment is safe for further testing, but it remains experimental and is not yet approved by the FDA.12345

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for pancreatic cancer, which typically involve chemotherapy, radiation, or surgery, LOAd703 introduces a novel approach using oncolytic virus therapy. This treatment employs a virus engineered to selectively infect and kill cancer cells, while also boosting the body's immune response against the tumor. In one arm of the study, LOAd703 is combined with atezolizumab, an immune checkpoint inhibitor, to potentially enhance the immune system's ability to fight the cancer. Researchers are excited because this dual-action strategy could offer a more targeted and effective treatment option for pancreatic cancer, with the potential to improve outcomes compared to conventional therapies.

What evidence suggests that LOAd703 might be an effective treatment for pancreatic cancer?

Research has shown that LOAd703, a virus used to fight cancer, may help treat pancreatic cancer. In this trial, one group of participants will receive LOAd703 with chemotherapy, which studies have demonstrated to have significant cancer-fighting effects. Some patients experienced tumor shrinkage or had their cancer remain stable for extended periods. LOAd703 attacks cancer cells directly and enhances the immune system's ability to fight cancer. In another group, LOAd703 will be combined with the drug atezolizumab. This combination has been well-tolerated, and some patients have responded positively. While more research is needed, these early results offer promise for those considering this treatment.12367

Who Is on the Research Team?

AL

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm 2: Intratumoral LOAd703 + atezolizumabExperimental Treatment4 Interventions
Group II: Arm 1 Intratumoral LOAd703Experimental Treatment3 Interventions

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

🇺🇸
Approved in United States as LOAd703 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lokon Pharma AB

Lead Sponsor

Trials
3
Recruited
120+

Published Research Related to This Trial

Nanoliposomal irinotecan combined with 5-fluorouracil/folinic acid has been approved as the first second-line treatment for metastatic pancreatic cancer, showing significant improvements in progression-free survival (3.1 months vs. 1.5 months) and overall survival (6.2 months vs. 4.1 months) compared to 5-FU/folinic acid alone.
Patients receiving this combination therapy may experience more frequent adverse effects like neutropenia, fatigue, and diarrhea, necessitating careful monitoring and potential dose adjustments, especially for those with specific UGT1A1 gene variants.
Update on the role of nanoliposomal irinotecan in the treatment of metastatic pancreatic cancer.Rahman, FAU., Ali, S., Saif, MW.[2020]
In a small clinical study involving 3 patients with stage IV pancreatic cancer, the gene therapy Rexin-G successfully arrested tumor growth in all participants without causing dose-limiting toxicity or significant side effects.
Two of the patients remained alive with stable disease for 5 and 14 months post-diagnosis, indicating potential efficacy of Rexin-G as a treatment option, which will inform future phase I/II clinical trials.
First clinical experience using a 'pathotropic' injectable retroviral vector (Rexin-G) as intervention for stage IV pancreatic cancer.Gordon, EM., Cornelio, GH., Lorenzo, CC., et al.[2022]
Recent phase I trials have shown that several novel treatments for pancreatic adenocarcinoma, including a MEK inhibitor and a connective tissue growth factor inhibitor, are safe for patients.
These promising treatments, along with others tested, will undergo phase II trials to determine their potential effectiveness in treating this challenging cancer.
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.Dimou, AT., Syrigos, KN., Saif, MW.[2022]

Citations

LOAd703, an oncolytic virus-based immunostimulatory ...The aim of this study was to evaluate the safety and feasibility of combining LOAd703 with chemotherapy for advanced pancreatic ductal adenocarcinoma. Methods.
A Single-Arm, Phase I/II Study of LOAd703, an Oncolytic Virus ...Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369(18):1691–703. [DOI] [PMC free article] [PubMed] [Google ...
LOAd703 Oncolytic Virus Therapy for Pancreatic CancerThe purpose of this study is to see if LOAd703 (an oncolytic adenovirus) can be safely given to patients with pancreatic cancer.
LOAd703 and chemotherapy combination in pancreatic ...The combination of LOAd703 and chemotherapy demonstrated promising anticancer activity in pancreatic cancer. However, further evaluation of ...
A phase I/II clinical trial22% experienced clinical benefit with partial response (n ¼ 6) or long-lasting stable disease ( 5 months, n ¼ 3). All patients who experienced partial response ...
Delolimogene mupadenorepvec - Drug Targets, ...The aim of this study was to evaluate the safety and feasibility of combining LOAd703 with chemotherapy for advanced pancreatic ductal adenocarcinoma. METHODS:.
delolimogene mupadenorepvec (LOAd703) / Lokon... pancreatic cancer and received LOAd703 combined with gemcitabine and nab-paclitaxel. Indication of clinical benefit in a subset of patients combined with ...
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