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Virus Therapy

Oncolytic Virus Therapy for Pancreatic Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Lokon Pharma AB

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be eligible for standard of care treatment with gemcitabine +nab-paclitaxel

Patient is not eligible for a complete surgical resection of their disease as evaluated by a radiologist and/or surgeon

Must not have

Any concurrent treatment that would compromise the study including but not limited to continuous high dose corticosteroids (>10 mg/day of prednisone equivalence), lymphodepleting antibodies or cytotoxic agents

Moderate to large volume ascites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a virus that has been modified to attack cancer cells and also stimulate the immune system to help kill cancer cells. The virus will be injected into the tumor and the patient will also receive standard care treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include fever after injection due to immune response activation. There may also be typical chemotherapy-related side effects like fatigue, nausea, low blood counts leading to increased infection risk; plus potential reactions related to atezolizumab such as organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for treatment with gemcitabine and nab-paclitaxel.

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My cancer cannot be completely removed by surgery.

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I am not pregnant and agree to use birth control during the study.

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My liver tests are within normal limits.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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I have been diagnosed with pancreatic cancer.

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My kidney function is within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on any treatments that could interfere with the study, such as high dose steroids or certain immune system targeting drugs.

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I have a noticeable amount of fluid in my abdomen.

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I have had cancer spread to the lining of my brain and spinal cord.

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I have had a stem cell or organ transplant in the past.

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I haven't taken any immune-boosting drugs in the last 4 weeks or longer.

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I have not had a recent heart attack, stroke, severe heart failure, or uncontrolled heart rhythm problems.

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I have not had biologic therapy in the last 21 days.

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I do not have active hepatitis B or C, HIV, or tuberculosis.

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I haven't had major surgery in the last 4 weeks and don't expect to need any during the study.

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I frequently need procedures to remove excess fluid from my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patient with dose-limiting toxicities (DLTs) as evaluated accordingly to CTCAE 4.0

Secondary study objectives

Overall Response Rate

Overall Survival

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

delolimogene mupadenorepvec

2020

Completed Phase 2

~30

Gemcitabine

FDA approved

Atezolizumab

FDA approved