Phase 2 Pancreatic Cancer Trial, Recruiting NCT05776524 Sponsor: THERABIONIC INC. Condition: Pancreatic Cancer
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Phase 2 Pancreatic Cancer Trial, Recruiting

NCT05776524
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 newly diagnosed with metastatic pancreatic adenocarcinoma (a specific type of pancreatic cancer that has spread to other parts of the body) that has been confirmed by biopsy and has not yet been treated.
  • People who have at least one measurable tumor that has spread to another part of the body, visible on a CT or MRI scan of the chest, abdomen, and pelvis.
  • People aged 18 or older.
  • People who are generally well enough to carry out light activity and care for themselves, based on a standard medical fitness scale (ECOG score of 0 or 1).
  • People whose blood counts, liver function, and kidney function meet the required levels (the trial site can confirm whether results meet these requirements; blood or platelet transfusions are allowed beforehand if needed to meet these levels).
  • People who are willing and able to understand and sign a consent form, either personally or through a legally authorised representative.
  • Women who could become pregnant, and men whose partners could become pregnant, who agree to use two forms of contraception during treatment and for six months after treatment ends, and who will inform their treating doctor immediately if pregnancy occurs or is suspected during the trial.

Who may not be able to join:

  • People who have previously received chemotherapy for metastatic pancreatic cancer, or who received gemcitabine and/or nab-paclitaxel chemotherapy within six months before entering the study (even if given before the cancer spread).
  • People who have previously received FOLFIRINOX chemotherapy before the cancer spread are still eligible (confirm with trial site).
  • People who have cancer that has spread to the brain.
  • People with a known allergy or serious reaction to gemcitabine, nab-paclitaxel, or chemically similar substances.
  • People who have had another cancer in the past three years, with the exception of certain early-stage or low-risk cancers such as cervical cancer in situ, treated skin cancers, or treated low-risk prostate cancer (confirm with trial site).
  • People currently taking calcium channel blocker medications — such as amlodipine, nifedipine, or ethosuximide — unless those medications can be stopped before joining the trial.
  • People with an active, uncontrolled infection (bacterial, viral, or fungal) that requires ongoing systemic treatment, though re-evaluation may be possible once the infection is under control and treatment is completed.
  • People with serious uncontrolled health conditions such as heart failure, unstable chest pain, heart rhythm problems, or mental health or personal circumstances that could make it difficult to safely follow the trial requirements.
  • People who have been diagnosed with certain lung conditions, including interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis.
  • Women who are pregnant or breastfeeding.
  • People whose pancreatic cancer has not spread and could potentially be removed by surgery, or whose cancer is locally advanced only (has not spread to other organs).
  • People who have had major surgery within four weeks before the treatment start date (minor procedures or diagnostic surgery are generally acceptable — confirm with trial site).
  • People who are unable to follow the trial procedures, or who anticipate a break from treatment of 14 or more consecutive days after starting the trial.
  • People who are currently participating in another clinical trial or taking another experimental treatment.

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 21 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

Principal Investigator: Ravi Paluri, MD, Wake Forest Baptist Comprehensive Cancer Center

Phone: 3367136912

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
THERABIONIC INC.
Registry
ClinicalTrials.gov
Start date
13 June 2023
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall Survival

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: 21 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