Pancreatic CancerPhase 1/2NCT02705196
LOAd703 Oncolytic Virus Therapy for Pancreatic Cancer
A Phase 1/2 study testing delolimogene mupadenorepvec, gemcitabine and nab-paclitaxel in people with Pancreatic Cancer, run by Lokon Pharma AB at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- delolimogene mupadenorepvec, gemcitabine and nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2016to 15 Nov 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ductal adenocarcinoma of the pancreas (PDAC).
- Low tumor burden with at least one lesion that is suitable for image-guided intratumoral injection and needle biopsy.
- The patient is not eligible for a complete surgical resection of their disease as evaluated by a radiologist and/or surgeon.
- Patients who may receive the injections endoscopically should be eligible for sedation.
- The patient must be eligible for standard of care treatment with gemcitabine +nab-paclitaxel.
- Age ≥ 18 yrs of age
Show all 12Show fewer
- Females of childbearing potential must have a negative pregnancy test and agree to use contraception during on-study protocol treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Absolute neutrophil count (ANC) ≥1.0 x 10^9/l, hemoglobin ≥9 g/dl, platelet count ≥ 100 x 10^9/l, prothrombin (INR) <1.5.
- Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 2.5 x ULN
- Adequate renal function with serum creatinine <2 x the ULN or creatinine clearance >30 mL/min
- The patient must provide informed consent.
Who cannot join
- 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.
- Treatment with high dose immune inhibitors including lymphotoxic monoclonal antibodies such as alemtuzumab (Campath), or rapamycin/rapalogs or cytotoxic agents within 21 days of registration
- Treatment with biologic therapy within 21 days of registration.
- Use of any investigational agents within 21 days of registration.
- The use of systemic immunostimulatory agents (including, but not limited to, interferons and IL-2) are prohibited within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment and during study treatment because these agents could potentially increase the risk for autoimmune conditions when given in combination with atezolizumab
- Pregnant or breastfeeding females.
Show all 24Show fewer
- Known active hepatitis B or C infection, HIV infection or tuberculosis.
- Patients with active autoimmune disease or immune deficiency or previous Guillain-Barre syndrome. Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g. patients with psoriatic arthritis are excluded) are eligible for the study provide all of the following conditions are met:
- Rash must cover <10% of body surface area
- Disease is well controlled at baseline and requires only low-potency topical corticosteroids
- No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors or high-potency or oral corticosteroids within the previous 12 months
- Uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that in the opinion of the Investigator would compromise compliance of study requirements or put the patient at unacceptable risk.
- Other malignancies within the past 2 years (not including basal cell carcinoma of the skin, prostate cancer or in situ cervix carcinoma).
- Moderate to large volume ascites.
- History of leptomeningeal disease.
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis on screening chest computed tomography (CT) scan. However, history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Unstable angina, uncontrolled cardiac arrhythmia, recent (within 3 months) history of myocardial infarction or stroke or New York Class III/IV congestive heart failure
- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the study.
- Prior allogeneic stem cell or solid organ transplantation.
- History of severe allergic anaphylactic reactions to chimeric human or humanized antibodies or fusion proteins.
- Known hypersensitivity to CHO cell products or any component of the atezolizumab formulation.
- Live attenuated vaccines (e.g. FluMist) are prohibited within 4 weeks prior to initiation of study treatment, during atezolizumab treatment, and for 5 months after the final dose of atezolizumab.
- Adenovirus-based vaccines (e.g Vaxzevria, known as COVID-19 vaccine Astra Zeneca, J\&J Covid-19 vaccine) are prohibited 3 months prior to initation of study treatment, during treatment and 6 months after the final dose of LOAd703
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
Baylor St Luke's Medical Center
Houston, Texas, 77030
About this study
Official title: Phase I/IIa Trial Evaluating Safety of LOAd703, an Armed Oncolytic Adenovirus for Pancreatic Cancer
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.
Read more
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.
Read the detailed description
The research will be conducted at Baylor College of Medicine (BCM) and Baylor St. Luke's Medical Center (BSLMC).
All patients will receive standard of care treatment for their pancreatic cancer. Standard of care treatment will be gemcitabine in combination with nab-paclitaxel given on days 1, 8, and 15 of a 28 day cycle.
Arm 1: LOAd703 treatment will be initiated at day 15 of the first cycle and given every other week for 6 doses. Depending on the location of the tumor the injection of LOAd703 can be given in different ways. The most common route of injection is ultrasound-guided percutaneous injection, but endoscopic ultrasound-guidance will be used for some patients as appropriate. All patients will receive anti-anxiety drugs or sedation as needed for comfort during the procedure. This study evaluates different doses of LOAd703. All patients will receive six injections of LOAd703. If patients in either phase of the study are judged by the investigator to be deriving clinical benefit from LOAd703 once all scheduled injections have been administered, they will be eligible to receive up to 6 additional biweekly doses of LOAd703.
Arm 2: the same procedures as arm 1 in regard to LOAd703. In addition, the arm 2 patients will receive atezolizumab at a fixed dose, every chemotherapy cycle day 1. The treatments can continue until the final follow-up visit.
Follow-up visits: Besides visits to receive treatments, patients will continue to visit BCM/BSLMC or their local doctor for evaluation of health status and side effects. At some visits blood samples will be obtained. Some of the blood samples being obtained are considered standard of care to ensure patient safety for standard of care treatment and the LOAd703 injection. However, some blood and biopsy samples (in applicable patients) will be collected to be analyzed for the presence of LOAd703, atezolizumab tumor markers and immunology markers. The extra blood will be 5-15 ml (3 teaspoonfuls) of blood collected at the screening visit and at eight different time points both during treatment and after treatments are completed. Imaging of the tumor to determine tumor size will be done every two to three months, which is routine for the monitoring of patients with pancreatic cancer. Patients will actively participate in the study for about 9 months when the final follow-up visit will be scheduled (or 12 months if additional doses of LOAD703 are given). After their active participation is completed patients will continue to receive routine care and will be contacted by the study team every 3 months to provide follow up on the status of their disease.
- Conditions
- Pancreatic Cancer
- Being tested
- delolimogene mupadenorepvec, gemcitabine, nab-paclitaxel, atezolizumab
- Keywords
- oncolytic, adenovirus, pancreatic, cancer, LOKON, LOAd703
- Medical subject headings
- Pancreatic Neoplasms, Adenoviridae Infections, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delolimogene mupadenorepvecGenetic
Also called LOAd703
oncolytic virus encoding TMZ-CD40L and 4-1BBL
gemcitabineDrug
Also called Gemzar
chemotherapy
nab-paclitaxelDrug
Also called Abraxane
chemotherapy
atezolizumabBiological
Also called Tecentriq
anti-PD-L1 antibody
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Intratumoral LOAd703 | Experimental | 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 Receives: Genetic: delolimogene mupadenorepvec; Drug: gemcitabine; Drug: nab-paclitaxel |
| Arm 2: Intratumoral LOAd703 + atezolizumab | Experimental | 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 Receives: Genetic: delolimogene mupadenorepvec; Drug: gemcitabine; Drug: nab-paclitaxel; Biological: atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with dose-limiting toxicities (DLTs) as evaluated accordingly to CTCAE 4.0
Maximum tolerated dose of multiple (6x) image-guided intratumoral injections of LOAd703 at three dose levels in combination with standard of care therapy
Measured: 9 months
Secondary outcomes (2)
Overall Response Rate
To determine the percentage of subjects achieving a partial response or better (according to RECIST 1.1) to repeat doses of LOAd703 (at the highest dose as determined in Phase I) combined with standard of care treatment with and without atezolizumab in pancreatic cancer.
Measured: 9 months
Overall Survival
To determine the survival days post study initiation
Measured: 6 months post last patient, last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startNov 2016
- Primary completion15 Nov 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokon Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angelica Loskog, PhD, Study chair, Lokon Pharma AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705196
- Sponsor's protocol ID
- LOKON001
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2016
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Musher BL, Rowinsky EK, Smaglo BG, Abidi W, Othman M, Patel K, Jawaid S, Jing J, Brisco A, Leen AM, Wu M, Sandin LC, Wenthe J, Eriksson E, Ullenhag GJ, Grilley B, Leja-Jarblad J, Hilsenbeck SG, Brenner MK, Loskog ASI. LOAd703, an oncolytic virus-based immunostimulatory gene therapy, combined with chemotherapy for unresectable or metastatic pancreatic cancer (LOKON001): results from arm 1 of a non-randomised, single-centre, phase 1/2 study. Lancet Oncol. 2024 Apr;25(4):488-500. doi: 10.1016/S1470-2045(24)00079-2.
PubMed 38547893
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa Trial Evaluating Safety of LOAd703, an Armed Oncolytic Adenovirus for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02705196
- Acronym / sponsor ID
- LOKON001
- Conditions
- Pancreatic Cancer
- Keywords
- oncolytic, adenovirus, pancreatic, cancer, LOKON, LOAd703
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Lokon Pharma ABIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research will be conducted at Baylor College of Medicine (BCM) and Baylor St. Luke's Medical Center (BSLMC).
All patients will receive standard of care treatment for their pancreatic cancer. Standard of care treatment will be gemcitabine in combination with nab-paclitaxel given on days 1, 8, and 15 of a 28 day cycle.
Arm 1: LOAd703 treatment will be initiated at day 15 of the first cycle and given every other week for 6 doses. Depending on the location of the tumor the injection of LOAd703 can be given in different ways. The most common route of injection is ultrasound-guided percutaneous injection, but endoscopic ultrasound-guidance will be used for some patients as appropriate. All patients will receive anti-anxiety drugs or sedation as needed for comfort during the procedure. This study evaluates different doses of LOAd703. All patients will receive six injections of LOAd703. If patients in either phase of the study are judged by the investigator to be deriving clinical benefit from LOAd703 once all scheduled injections have been administered, they will be eligible to receive up to 6 additional biweekly doses of LOAd703.
Arm 2: the same procedures as arm 1 in regard to LOAd703. In addition, the arm 2 patients will receive atezolizumab at a fixed dose, every chemotherapy cycle day 1. The treatments can continue until the final follow-up visit.
Follow-up visits: Besides visits to receive treatments, patients will continue to visit BCM/BSLMC or their local doctor for evaluation of health status and side effects. At some visits blood samples will be obtained. Some of the blood samples being obtained are considered standard of care to ensure patient safety for standard of care treatment and the LOAd703 injection. However, some blood and biopsy samples (in applicable patients) will be collected to be analyzed for the presence of LOAd703, atezolizumab tumor markers and immunology markers. The extra blood will be 5-15 ml (3 teaspoonfuls) of blood collected at the screening visit and at eight different time points both during treatment and after treatments are completed. Imaging of the tumor to determine tumor size will be done every two to three months, which is routine for the monitoring of patients with pancreatic cancer. Patients will actively participate in the study for about 9 months when the final follow-up visit will be scheduled (or 12 months if additional doses of LOAD703 are given). After their active participation is completed patients will continue to receive routine care and will be contacted by the study team every 3 months to provide follow up on the status of their disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Intratumoral LOAd703 | Experimental | Genetic: delolimogene mupadenorepvec, Drug: gemcitabine, Drug: nab-paclitaxelPatients 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 |
| Arm 2: Intratumoral LOAd703 + atezolizumab | Experimental | Genetic: delolimogene mupadenorepvec, Drug: gemcitabine, Drug: nab-paclitaxel, Biological: atezolizumabPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of ductal adenocarcinoma of the pancreas (PDAC).
- Low tumor burden with at least one lesion that is suitable for image-guided intratumoral injection and needle biopsy.
- The patient is not eligible for a complete surgical resection of their disease as evaluated by a radiologist and/or surgeon.
- Patients who may receive the injections endoscopically should be eligible for sedation.
- The patient must be eligible for standard of care treatment with gemcitabine +nab-paclitaxel.
Key exclusion criteria (24 listed)
- 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.
- Treatment with high dose immune inhibitors including lymphotoxic monoclonal antibodies such as alemtuzumab (Campath), or rapamycin/rapalogs or cytotoxic agents within 21 days of registration
- Treatment with biologic therapy within 21 days of registration.
- Use of any investigational agents within 21 days of registration.
- The use of systemic immunostimulatory agents (including, but not limited to, interferons and IL-2) are prohibited within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment and during study treatment because these agents could potentially increase the risk for autoimmune conditions when given in combination with atezolizumab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| delolimogene mupadenorepvecAlso: LOAd703oncolytic virus encoding TMZ-CD40L and 4-1BBL | Genetic | Arm 1 Intratumoral LOAd703, Arm 2: Intratumoral LOAd703 + atezolizumab |
| gemcitabineAlso: Gemzarchemotherapy | Drug | Arm 1 Intratumoral LOAd703, Arm 2: Intratumoral LOAd703 + atezolizumab |
| nab-paclitaxelAlso: Abraxanechemotherapy | Drug | Arm 1 Intratumoral LOAd703, Arm 2: Intratumoral LOAd703 + atezolizumab |
| atezolizumabAlso: Tecentriqanti-PD-L1 antibody | Biological | Arm 2: Intratumoral LOAd703 + atezolizumab |
Primary outcome
Number of patient with dose-limiting toxicities (DLTs) as evaluated accordingly to CTCAE 4.0
Time frame: 9 months
Maximum tolerated dose of multiple (6x) image-guided intratumoral injections of LOAd703 at three dose levels in combination with standard of care therapy
2 secondary outcomes
Overall Response Rate
Time frame: 9 months
Overall Survival
Time frame: 6 months post last patient, last visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Derived from this study: PubMed 38547893Musher BL, Rowinsky EK, Smaglo BG, Abidi W, Othman M, Patel K, Jawaid S, Jing J, Brisco A, Leen AM, Wu M, Sandin LC, Wenthe J, Eriksson E, Ullenhag GJ, Grilley B, Leja-Jarblad J, Hilsenbeck SG, Brenner MK, Loskog ASI. LOAd703, an oncolytic virus-based immunostimulatory gene therapy, combined with chemotherapy for unresectable or metastatic pancreatic cancer (LOKON001): results from arm 1 of a non-randomised, single-centre, phase 1/2 study. Lancet Oncol. 2024 Apr;25(4):488-500. doi: 10.1016/S1470-2045(24)00079-2.
- Sponsors websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelica Loskog, PhD study chair
Lokon Pharma AB
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing delolimogene mupadenorepvec, gemcitabine and nab-paclitaxel in people with Pancreatic Cancer, run by Lokon Pharma AB at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient with dose-limiting toxicities (DLTs) as evaluated accordingly to CTCAE 4.0 (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02705196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.