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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests Saltikva, a safe, modified Salmonella bacteria that delivers an immune booster directly to tumors, in patients with advanced pancreatic cancer. The goal is to see if adding Saltikva to standard chemotherapy can help patients live longer and slow down the progression of their disease.

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.

What data supports the effectiveness of the treatment Saltikva for Pancreatic Cancer?

Research shows that Salmonella engineered to express IL2 can boost the immune system's natural killer cells, which are important for fighting cancer. In animal studies, similar treatments have slowed tumor growth and improved survival, suggesting potential benefits for cancer therapy. ^{1 2 3 4 5}

Is Saltikva safe for human use?

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. ^{1 2 3 4 6}

How does the treatment Saltikva differ from other treatments for pancreatic cancer?

Saltikva is unique because it uses a genetically modified strain of Salmonella bacteria to deliver interleukin-2, a protein that can boost the immune system, directly to tumors. This approach aims to enhance the body's natural immune response against cancer cells without causing significant toxicity, unlike traditional systemic treatments. ^{1 3 6 7 8}

Research Team

Gerald Batist, MD

Principal Investigator

McGill University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Antitumour effects of genetically engineered Salmonella in combination with radiation. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Combining DNA Vaccine and AIDA-1 in Attenuated Salmonella Activates Tumor-Specific CD4+ and CD8+ T-cell Responses. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A Phase I, Dose Escalation, Single Dose Trial of Oral Attenuated Salmonella typhimurium Containing Human IL-2 in Patients With Metastatic Gastrointestinal Cancers. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Potent anti-tumor activity of systemically-administered IL2-expressing Salmonella correlates with decreased angiogenesis and enhanced tumor apoptosis. [2008]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Tumor-Targeting Salmonella A1-R on a Melanoma Patient-Derived Orthotopic Xenograft (PDOX) Nude-Mouse Model. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Immunotherapy of a plasmacytoma with attenuated salmonella. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

T cell augments the antitumor activity of tumor-targeting Salmonella. [2011]

8. United States pubmed.ncbi.nlm.nih.gov

Persistent salmonellosis causes pancreatitis in a murine model of infection. [2021]