Saltikva for Pancreatic Cancer

Overseen By Peter Kavan, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Salspera LLC

Must be taking: Chemotherapy

Must not be taking: Immunosuppressants, Antibiotics

Disqualifiers: Brain metastases, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Saltikva, which uses a type of bacteria modified to fight cancer, combined with standard chemotherapy for people with advanced pancreatic cancer. The goal is to determine if adding Saltikva can help patients live longer and slow the disease. Researchers will test two different chemotherapy combinations, dividing patients into groups to receive either FOLFIRINOX or Gemcitabine/Abraxane with Saltikva. The trial seeks participants with pancreatic cancer that has spread and cannot be surgically removed. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering a chance to contribute to important advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressive medications or require ongoing antibiotics for preventive reasons. If you are taking medications for heart rate control, you must be stable on them for at least a month before starting the trial.

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

Research has shown that Saltikva, a treatment combining a type of bacteria with a protein called IL-2, appears to be safe. In one study with 22 patients, researchers observed no harmful side effects, suggesting it is safe for people. Another study found no serious issues with doses up to 10 billion CFU, a measure of the bacteria. This treatment might help people with advanced pancreatic cancer, and current evidence suggests it is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Salmonella-IL2 treatments for pancreatic cancer because they harness a unique mechanism involving genetically modified bacteria. Unlike traditional chemotherapy drugs like FOLFIRINOX or Gemcitabine/Abraxane, which target cancer cells directly, Salmonella-IL2 uses a bacteria-based delivery system to stimulate the immune system, potentially enhancing its ability to fight cancer. This innovative approach could lead to more targeted and effective treatment with fewer side effects, offering hope for improved outcomes in a challenging-to-treat cancer.

What evidence suggests that this trial's treatments could be effective for metastatic pancreatic cancer?

In this trial, participants will receive Salmonella-IL2 combined with standard treatments for stage IV metastatic pancreatic cancer. Research has shown that adding Salmonella-IL2 to the chemotherapy treatment FOLFIRINOX yields promising results, with patients living nearly twice as long on average. Specifically, the average survival time was 24 months compared to 13.1 months for those not receiving Salmonella-IL2. These findings suggest that Salmonella-IL2 could significantly extend life and slow disease progression in patients with advanced pancreatic cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Gerald Batist, MD

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with metastatic pancreatic cancer that can't be surgically removed. Participants need to have a certain level of physical fitness, life expectancy over 16 weeks, and meet specific blood test criteria. They must not be on other experimental drugs or immunosuppressants, have brain metastases, uncontrolled illnesses like heart failure or infections, or significant cardiovascular disease.

Inclusion Criteria

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

You have enough infection-fighting white blood cells.

You are expected to live for more than 16 weeks.

Exclusion Criteria

I am taking immunosuppressive drugs for a condition like an autoimmune disease.

I am on long-term antibiotics to prevent infections.

Pregnant women are excluded from this study; breastfeeding should be discontinued

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Saltikva with either FOLFIRINOX or Gemcitabine/Abraxane every 2-3 weeks for 2 years

24 months

Bi-weekly or tri-weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Salmonella-IL2

Trial Overview The trial tests Saltikva (a modified Salmonella bacteria expressing IL-2) combined with standard chemotherapy (FOLFIRINOX or Gemcitabine/Abraxane). The goal is to see if adding Saltikva improves survival and slows down the cancer compared to just the standard chemo treatments.

How Is the Trial Designed?

Group I: Saltikva with Gemcitabine/Abraxane Experimental Treatment 2 Interventions

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

Group II: Saltikva with FOLFIRINOX Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Salspera LLC

Lead Sponsor

Trials

1

Recruited

60+

Published Research Related to This Trial

The attenuated strain of Salmonella typhimurium, SL3235, demonstrated significant antitumor activity against a rapidly growing murine plasmacytoma, TEPC-183, leading to prolonged survival in tumor-bearing mice when administered intralesionally or intraperitoneally.

The effectiveness of the Salmonella treatment was influenced by the timing of administration and the dosage, with lower doses proving more effective than higher doses, suggesting a potential for this genetically engineered strain as a novel immunotherapeutic agent in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy of a plasmacytoma with attenuated salmonella. Eisenstein, TK., Bushnell, B., Meissler, JJ., et al.[2019]

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/83/8_Supplement/CT035/725265/Abstract-CT035-Addition-of-Salmonella-IL2-to

Abstract CT035: Addition of Salmonella-IL2 to FOLFIRINOX for ... Addition of Salmonella-IL2 to FOLFIRINOX for stage 4 metastatic pancreatic cancer results in the near doubling of median survival.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04589234

NCT04589234 | Saltikva for Metastatic Pancreatic Cancer The addition of Saltikva to the standard of care regimen for Stage IV metastatic pancreatic cancer will significantly prolong the overall survival.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.2571

Influence of salmonella-IL2 in combination with ... Conclusions: Addition of Salmonella-IL2 to FOLFIRINOX for treating stage IV pancreatic cancer is associated with increased mPFS and mOS. A ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7458080/

A Phase I, Dose Escalation, Single Dose Trial of Oral ... The results of this Phase I dose escalation study show that a single oral dose of Saltikva caused no significant toxicities up to doses of 1010 CFU. The most ...

5. cancertherapyadvisor.com cancertherapyadvisor.com/reports/salmonella-il2-folfirinox-pancreatic-cancer-stage-iv/

Salmonella-IL2 May Improve Upon FOLFIRINOX in Stage ... The median overall survival was 24 months in patients treated with Salmonella-IL2 and FOLFIRINOX, 13.1 months in the site-specific control group ...

6. withpower.com withpower.com/trial/phase-3-pancreatic-neoplasms-9-2020-a6411

Saltikva for Pancreatic Cancer · Info for Participants In a study with 22 patients who took Saltikva, no toxicity or harmful side effects were observed, suggesting it is generally safe for human use.