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Metastatic Pancreatic CancerPhase 2NCT04589234

Saltikva for Metastatic Pancreatic Cancer

A Phase 2 study testing Salmonella-IL2 in people with Metastatic Pancreatic Cancer, run by Salspera LLC at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Objectives: Assess the efficacy of multiple dose oral administration of Saltikva, an attenuated strain of Salmonella Typhimurium expressing IL-2, in patients with metastatic pancreatic cancer on standard chemotherapy (either FOLFIRINOX or Gemcitabine/Abraxane and Saltikva). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Salmonella-IL2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
20 Oct 2020to 31 Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Patients must have a histologically confirmed, unresectable metastatic pancreatic adenocarcinoma
  • Measurable disease will be required
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Life expectancy of greater than 16 weeks
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
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  • Platelets >= 100,000/mcL
  • Total bilirubin =< 1.5 institutional upper limit of normal (IULN)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X IULN if no liver metastasis or =< 5 X IULN if liver metastases are present
  • Creatinine not to be above IULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of Saltikva administration
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients who are receiving any other investigational agents
  • Patients who are on immunosuppressive medications for any reason including for autoimmune diseases, organ transplantation, or hematologic conditions such as myelodysplastic syndrome.
  • Patients that require ongoing antibiotics for a prophylactic reason - for example patients with chronic or frequently recurrent urinary tract infections are placed on suppressive or prophylactic antibiotics
  • Patients with known brain metastases should be excluded from this clinical trial
  • History of allergic reactions attributed to compounds of similar biologic composition to Saltikva.
  • Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with Saltikva but the hyperglycemia should be well controlled before the patient enters the trial (glycosylated hemoglobin [Hba1c] < 7.5)
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  • Patients with current evidence of significant cardiovascular disease (New York Heart Association class III or IV cardiac disease), symptomatic congestive heart failure, dilated/hypertrophic or restrictive cardiomyopathy, myocardial infarction (within the past 6 months), unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy (use of medications for rate control for atrial fibrillation is allowed such as calcium channel blockers and beta-blockers, if stable medication for at least last month prior to initiation of Saltikva.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study; breastfeeding should be discontinued.
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible. Patients with active Hepatitis B or C infection are ineligble
  • Clinically significant ascites

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Segal Cancer Centre/ Mortimer B. Davis-Jewish General Hosptial

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

Official title: A Phase 2 Study of Saltikva (Attenuated Salmonella Typhimurium Containing the Human Gene for Interleukin-2) in Patients With Metastatic Pancreatic Cancer

Objectives: Assess the efficacy of multiple dose oral administration of Saltikva, an attenuated strain of Salmonella Typhimurium expressing IL-2, in patients with metastatic pancreatic cancer on standard chemotherapy (either FOLFIRINOX or Gemcitabine/Abraxane and Saltikva).

Study Rationale: The addition of Saltikva to the standard of care regimen for Stage IV metastatic pancreatic cancer will significantly prolong the overall survival and prolong the time to disease progression.

Patient Population: unresectable, metastatic pancreatic cancer patients 18 years of age or older

Read the detailed description

The study agent is Saltikva, an attenuated Salmonella Typhimurium containing the gene for human IL-2 (Salmonella-IL2). Salmonella is a human pathogen typically spread via contaminated water supplies or foodstuffs. After ingestion, these bacteria invade the intestinal mucosa and colonize the gut associated lymphoid tissues, the liver, and the spleen. If pathogenic, symptoms persist for 7 to 14 days. These organisms are thought to be facultative intracellular parasites, which can persistently infect the endothelium, kupfer cells, and parenchymal cells of the liver for up to 12 weeks. The liver is considered a 'safe-site' for Salmonella as the preferred organ of residence after infection. The carrier state is eventually eradicated by the stimulation of cell-mediated and secretory immunity. Saltikva is a Salmonella based cancer therapeutic that has been genetically altered so it is incapable of causing any disease and is unable to mutate to a wild-type form of Salmonella, thus can never become pathogenic or harm anyone. Furthermore, Saltikva has been shown to preferentially invade and colonize within solid tumor tissues at a ratio of 1,000-10,000:1 over the normal 'safe-sites' of the liver. In addition, the Salmonella of Saltikva carries the gene for a powerful anti-cancer immune stimulant, Interleukin-2. Thus, Saltikva's mode of action is to invade and colonize solid tumors after oral ingestion, release a powerful immune stimulant directly within the tumor microenvironment thus avoiding systemic side effects, and imparts an immunologic mediated cancer cell kill.

Hypothesis: The addition of Saltikva to the standard of care regimen for Stage IV metastatic pancreatic cancer will significantly prolong the overall survival and prolong the time to disease progression.

Rationale for study design Two standard of care chemotherapeutic regimens are used for pancreatic cancer, namely, FOLFIRINOX and a Gemcitabine-based regimen. Despite these regimens, the median survival from Stage 4 metastatic pancreas cancer is 11.1 and 6.8 months, respectively. Oncologists choose these regimens based on the assessment of which regimen will be tolerated by the individual patients the FOLFIRINOX regimen is significantly more toxic and not as well tolerated as a gemcitabine based regimen.

Because of the significant lethality of metastatic pancreatic cancer and numerous studies conducted world wide with the two chemotherapeutic strategies that will be used in this trial, the investigators will use historical controls as comparison to the study arms in this trial. Furthermore, because the outcomes of chemotherapy only in patients with metastatic pancreatic cancer has been well documented, the investigators do not see the need for a control arm in this study. Lastly, although the patient numbers are small, the preliminary data is quite promising, and it would be considered unethical to have a control arm in this study.

Being tested
Salmonella-IL2, FOLFIRINOX Alone (Historical Controls), Gemcitabine/Abraxane Alone (Historical Controls)
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Salmonella-IL2Drug

    Also called Saltikva

    Phase 2 study to determine the anti-tumor effectiveness of Salmonella-IL2 (Saltikva) with standard of care chemotherapy (either FOLFIRINOX or Gemcitabine/Abraxane) for metastatic pancreatic cancer

  • FOLFIRINOX Alone (Historical Controls)Drug

    We will use historical data from the literature to compare FOLFIRINOX alone against the FOLFIRINOX with Salmonella-IL2 group

  • Gemcitabine/Abraxane Alone (Historical Controls)Drug

    We will use historical data from the literature to compare Gemcitabine/Abraxane alone against the Gemcitabine/Abraxane with Salmonella-IL2 group

Study groups in NCT04589234
Study groupRoleWhat they receive
Saltikva with FOLFIRINOXExperimental30 patients will be enrolled to receive standard of care FOLFIRINOX with oral Salmonella-IL2 (Dose 10-9) every 2 weeks for 2 years
Receives: Drug: Salmonella-IL2; Drug: FOLFIRINOX Alone (Historical Controls)
Saltikva with Gemcitabine/AbraxaneExperimental30 patients will be enrolled to receive standard of care Gemcitabine/Abraxane with oral Salmonella-IL2 (Dose: 10-9) every 3 weeks for 2 years
Receives: Drug: Salmonella-IL2; Drug: Gemcitabine/Abraxane Alone (Historical Controls)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Survival from diagnosis to death from metastatic pancreatic cancer (months)

    Measured: 24 months

  2. Progression Free Survival

    Survival from diagnosis to progression of metastatic pancreatic cancer (months)

    Measured: 24 months

Secondary outcomes (2)

  1. Biological response

    Determination of CA19-9 levels (units per millimeter)

    Measured: 24 months

  2. Radiologic response

    Degree of tumor regression as determined by serial radiologic imaging (CT Scan, PET Scan, and/or MRI - percent change of tumor(s) volume (cubic millimeters)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start20 Oct 2020
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Design and Investigational Plan: Open-label, phase II, two arm, interventional, prospective, non-randomized multiple dose study in unresectable, metastatic pancreatic cancer patients 18 years of age or older Subject Number: 60 (30 per arm) Study Duration: 24 months per patient or when the patient ceases to be administered chemotherapy; whichever comes first
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04589234
Sponsor's protocol ID
SSP-20-006
Status last verified
May 2026
First submitted
23 Sep 2020
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Batist G, Kavan P, Augustin L, Schottel J, Moradian J, Lee JT, Saltzman D. A phase 2 study of orally administered live biotherapeutic salmonella-IL2 with FOLFIRINOX for stage IV pancreatic cancer. Cancer Immunol Immunother. 2026 Jan 27;75(2):60. doi: 10.1007/s00262-026-04307-0.

    PubMed 41591505

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Salmonella-IL2 in people with Metastatic Pancreatic Cancer, run by Salspera LLC at 1 site in Canada.

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 11 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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?

Overall Survival (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT04589234, 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 14 May 2026.

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