Phase 1 Pancreatic Cancer Trial, Recruiting NCT05013216 Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Condition: Pancreatic Cancer
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Phase 1 Pancreatic Cancer Trial, Recruiting

NCT05013216
Recruiting Phase 1

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 are considered high risk for developing pancreatic cancer (falling into one of three groups below) and are already taking part in a pancreatic monitoring programme, AND who have an abnormality found on a pancreas scan (such as a pancreatic cyst).

  • High Risk Group 1 (family history): People aged 55 or older (or at least 10 years younger than the youngest family member who had pancreatic cancer), who come from a family where 2 or more members have had pancreatic cancer, and where at least one of those relatives is a close (first-degree) family member such as a parent, sibling, or child.

  • High Risk Group 2 (certain gene mutations — higher risk): People aged 40 or older who carry the FAMMM (p16/CDKN2A) gene mutation, regardless of family history; OR people aged 50 or older (or 10 years younger than the youngest affected relative) who carry a BRCA2, ATM, or PALB2 gene mutation. Proof of mutation from an approved certified laboratory is required.

  • High Risk Group 3 (certain gene mutations — moderate risk): People aged 50 or older (or 10 years younger than the youngest affected relative) who carry a BRCA1 or Lynch syndrome (HNPCC)-related gene mutation, and who have more than one family member with pancreatic cancer, at least one of whom is a close (first- or second-degree) relative. Proof of mutation from an approved certified laboratory is required.

  • Cohort A participants: People already being monitored with pancreas scans (such as MRI, CT, or endoscopic ultrasound) for an abnormality such as a pancreatic cyst or other early tissue changes.

  • Cohort B participants: People with a pancreatic cyst that has features considered concerning enough by their surgeon to recommend surgical removal, and whose cyst fluid testing shows one of six specific KRAS gene mutations included in this study.

  • People whose organ and blood test results meet the health standards set out by the study.

  • People who are willing and able to sign a consent form confirming they understand the study.

  • Women who could become pregnant must have a negative pregnancy test and must follow the contraception guidelines set out in the study protocol.

  • Men must use an acceptable form of contraception during the study.


Who may not be able to join:

  • People who are expected to need other cancer treatments (systemic or localised) during the study period.

  • People who have used corticosteroids or immune-suppressing medications within 4 weeks before the first study treatment.

  • People who have received any experimental medical device, a live vaccine, allergen desensitisation therapy, or had major surgery within 4 weeks before the first study treatment.

  • People who have HIV, hepatitis B, or hepatitis C infection.

  • People with serious ongoing health conditions that are not well controlled, including serious infections, heart failure, unstable heart conditions, irregular heart rhythms, cancer that has spread to other parts of the body, or mental health or social circumstances that would make it difficult to follow the study schedule.

  • People who have been diagnosed with an immune system deficiency condition.

  • People who, in the opinion of the study doctor, have any other medical, psychological, or social reason that makes participation unsuitable (confirm with trial site).

  • People who are unwilling or unable to follow the study schedule.

  • People who are pregnant or breastfeeding.


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 9 July 2026
Phase 1: approximately ~10% 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: Nilofer Azad, MD, Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Medical Institution

Phone: 410-614-3644

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 1
Registry
ClinicalTrials.gov
Start date
11 April 2022
Est. completion
1 October 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of participants experiencing study drug-related toxicities; Maximal percentage of change of interferon (IFN-γ) producing mutant-KRAS-specific CD8 and CD4 T cells

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: 9 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