Phase 1 Oesophageal Cancer Trial, Recruiting NCT07001592 Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) Condition: Oesophageal Cancer
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Phase 1 Oesophageal Cancer Trial, Recruiting

NCT07001592
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:

  • You are between 18 and 69 years old at the time of signing the consent form
  • You have been diagnosed with cancer that started in the digestive system (such as the colon, stomach, or intestines) that has spread to other parts of the body, and your tumor has been tested for specific genetic markers called MSI and KRAS
  • If your tumor is a type called "microsatellite stable" (MSS), you must have already tried (or been unable to receive) the standard first and second rounds of chemotherapy; if your tumor is a type called "MSI-H," you must also have tried (or been unable to receive) immunotherapy
  • You are generally able to carry out normal daily activities with only minor difficulty (confirm with trial site)
  • Doctors expect you to live for at least 12 weeks
  • You are willing and able to sign an informed consent form, or have a legal representative who can do so on your behalf
  • Your blood counts are at acceptable levels, meaning your immune cells, red blood cells, and platelets are within required ranges (confirm with trial site)
  • Your kidneys are working well enough, based on a blood test result
  • Your liver is working well enough, based on a blood test result
  • Your blood clotting is within an acceptable range, and you are able to temporarily stop any blood-thinning medications for specific study procedures
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before joining
  • If you are sexually active, you must be willing to use both a reliable contraception method and a barrier method (such as a condom) from the start of the study until 6 weeks after receiving the study treatment
  • You are willing to follow all study procedures, care instructions, and attend all follow-up appointments
  • You have at least one area of cancer that can be measured on a scan
  • You have at least one tumor that is at least 1 cm across and can be safely injected directly

Who may not be able to join:

  • You are pregnant or currently breastfeeding
  • You have taken steroid medications or other drugs that suppress the immune system within the past 2 weeks
  • You have a significant problem with your immune system, or someone you live with does — and you would not be able to avoid close contact with that person for 3 weeks
  • You have an active infection or a serious uncontrolled health condition affecting the lungs, heart, nervous system, digestive system, or urinary system that the doctor considers too risky
  • You currently have active eczema, psoriasis, or another inflammatory skin condition
  • You have had a serious heart problem in the past 6 months, such as a heart attack, heart failure, heart muscle inflammation, or irregular heartbeat requiring medication; or your blood oxygen level is below 90% while resting and breathing normal air
  • You have received radiation, chemotherapy, or other immune-suppressing treatments within the past 2 weeks before screening, or within 4 weeks before receiving the study treatment
  • You had a severe reaction to a smallpox vaccine in the past
  • In the doctor's opinion, your medical condition makes it too risky for you to take part, or you may not be able to safely undergo the required tumor biopsies
  • You live with children under 5 years old, or with someone who has eczema, a skin condition, or a weakened immune system — unless you can make alternative living arrangements during your active treatment period and for 3 weeks afterward
  • You have received a live virus vaccine in the 60 days before the start of the study
  • You are unable or unwilling to give informed consent
  • You are unable or unwilling to attend the required follow-up visits

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 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: Patrick Wagner, MD, Allegheny Health Network

Phone: 412-359-3731

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
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Registry
ClinicalTrials.gov
Start date
6 May 2025
Est. completion
1 April 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of Treatment-Emergent Adverse Events (Safety) of vvDD-hIL-2-RG-1; Maximally-tolerated dose (MTD) of vvDD-hIL-2-RG-1; Maximum-feasible dose (MFD) of vvDD-hIL-2-RG-1

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