Saltikva for Metastatic Pancreatic Cancer

NCT04589234 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: SSP-20-006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Overall Survival

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

  24 months

• Progression Free Survival

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

  24 months

Secondary Outcomes (2)

• Biological response

  24 months

• Radiologic response

  24 months

Study Arms (2)

Saltikva with FOLFIRINOX

EXPERIMENTAL

30 patients will be enrolled to receive standard of care FOLFIRINOX with oral Salmonella-IL2 (Dose 10-9) every 2 weeks for 2 years

Drug: Salmonella-IL2; Drug: FOLFIRINOX Alone (Historical Controls)

Saltikva with Gemcitabine/Abraxane

EXPERIMENTAL

30 patients will be enrolled to receive standard of care Gemcitabine/Abraxane with oral Salmonella-IL2 (Dose: 10-9) every 3 weeks for 2 years

Drug: Salmonella-IL2; Drug: Gemcitabine/Abraxane Alone (Historical Controls)

Interventions

Salmonella-IL2 DRUG

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

Also known as: Saltikva

Saltikva with FOLFIRINOX; Saltikva with Gemcitabine/Abraxane

FOLFIRINOX Alone (Historical Controls) DRUG

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

Saltikva with FOLFIRINOX

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

Saltikva with Gemcitabine/Abraxane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Salspera LLC: lead

Study Sites (1)

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

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

• 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.

  PMID: 41591505 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinox; Gemcitabine; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Gerald Batist, MD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 19, 2020
• Study Start: October 20, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)