Phase 2 Pancreatic Cancer Trial, Recruiting NCT06861452 Sponsor: EIR Biotherapies s.r.l. Condition: Pancreatic Cancer
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Phase 2 Pancreatic Cancer Trial, Recruiting

NCT06861452
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with a confirmed type of pancreatic cancer called pancreatic ductal adenocarcinoma, specifically classified as "locally advanced" (meaning it has grown but has not spread to other parts of the body)
  • People whose cancer shows no signs of having spread to the lining of the abdomen or through the bloodstream to other organs
  • People whose cancer has been assessed by a team including at least an oncologist, a radiologist, and a qualified surgeon, and has been classified as unable to be removed by surgery, based on scans
  • People whose tumor can be measured using standard imaging guidelines (called RECIST criteria v1.1)
  • People who have at least one tumor area that is 3.5 cm or smaller and is suitable for a needle injection and biopsy guided by ultrasound
  • People whose general health and ability to carry out daily activities falls within an acceptable range (rated 0, 1, or 2 on a standard scale called the ECOG performance status)
  • People whose health condition means a treating doctor would consider them suitable for standard chemotherapy treatment
  • People aged 18 years or older
  • People with adequate liver, kidney, and blood function as assessed through testing
  • Women who could become pregnant must have a negative blood pregnancy test within the required timeframe before starting treatment
  • People who are willing and able to attend scheduled visits, follow the treatment plan, and take part in all study procedures, including a fat tissue collection procedure (liposuction)

Who may not be able to join:

  • People with a cystic (fluid-filled) pancreatic tumour or a pancreatic pseudocyst
  • People with a type of pancreatic tumour other than adenocarcinoma, such as an endocrine tumour or a tumour that has spread from another cancer
  • People whose pancreatic cancer stage is unknown or whose cancer has returned after previous treatment
  • People with a weakened immune system or known susceptibility to viral infections
  • People with active infections including HIV, hepatitis B, hepatitis C, HTLV-I/II, or syphilis (Treponema pallidum)
  • People with liver cirrhosis or other confirmed liver disease
  • People for whom chemotherapy would be medically unsuitable
  • People who have previously received radiotherapy or chemotherapy for pancreatic ductal adenocarcinoma
  • People who have previously had a stem cell transplant or an organ transplant
  • People with permanent, uncontrollable heart rhythm problems that require ongoing medication
  • People with heart failure rated above Grade II on the New York Heart Association scale
  • People who have had a heart attack, unstable angina, or severe stable angina within the past year
  • People with high blood pressure that is not well controlled
  • People who have had another cancer within the past two years (with some exceptions, such as certain skin, prostate, or cervical cancers — confirm with trial site)
  • People with an active autoimmune disease
  • People who have taken part in another clinical trial and received an experimental treatment within the 21 days before the study treatment begins
  • People who have had major open surgery shortly before the study treatment is due to start (confirm exact timeframe with trial site)
  • People with uncontrolled ongoing illness, including certain mental health or social circumstances that, in the investigator's view, could affect safe participation
  • People with a known or suspected allergy or sensitivity to a class of antibiotics called fluoroquinolones, including ciprofloxacin
  • People with a known or suspected allergy or sensitivity to protamine sulfate or products containing protamine — this may include people who have had certain heart procedures, people with diabetes who have used protamine insulin, people with a fish allergy, or men who have had a vasectomy or are infertile and may have developed antibodies to protamine

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: IT + 39 0594223808/0594225165

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
EIR Biotherapies s.r.l.
Registry
ClinicalTrials.gov
Start date
25 June 2025
Est. completion
29 July 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Evaluation of Safety in terms of monitoring of systemic tolerance, Adverse Events (AEs) and severe AEs (SAEs) assess by CTCAE (Version 5.0)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov