Phase 2 Type 1 Diabetes Trial, Recruiting NCT05824975 Sponsor: GI Innovation, Inc. Condition: Type 1 Diabetes
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Phase 2 Type 1 Diabetes Trial, Recruiting

NCT05824975
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:

  • You are 18 years of age or older (or 19 or older, depending on where the trial is being run).
  • Your heart, liver, kidneys, and other organs are functioning well enough to meet the trial's requirements (confirm with trial site).
  • Your cancer can be measured on scans, according to a standard set of guidelines called RECIST v1.1 (confirm with trial site).
  • You are generally well enough to carry out light activity and care for yourself — not bedridden or severely limited in daily activities (confirm with trial site).
  • Any side effects from previous cancer treatments or surgery have mostly cleared up, except for hair loss or mild nerve-related symptoms like tingling or numbness.
  • If you have HIV, you are on HIV medication and your HIV is well controlled.

Who may not be able to join:

  • Your cancer has spread to the brain or the lining around the brain and spinal cord, and it is currently active.
  • You have a second active cancer at this time.
  • You have an active Hepatitis B or Hepatitis C infection, or a known history of these infections.
  • You have active tuberculosis (TB) or a known history of active TB.
  • You have an active or uncontrolled infection, or had a serious infection within the last 4 weeks before starting the study.
  • You have a history of chronic liver disease or liver scarring (cirrhosis), unless your cancer has spread to your liver.
  • You have an autoimmune disease (where your immune system attacks your own body) that needed medical treatment in the past 2 years.
  • You have previously received certain types of immunotherapy treatments that work in a similar way to the drug being studied in this trial (confirm with trial site).
  • You have been diagnosed with a condition that weakens your immune system, or you have been taking steroids or other immune-suppressing medications in the past 2 weeks.
  • You have received any systemic cancer treatment, including experimental treatments, within the past 4 weeks.
  • You have had radiation therapy in the last 2 weeks before starting the trial, with the exception of small, targeted radiation given for pain relief.
  • You have received a live vaccine (such as certain flu or travel vaccines) within the past 4 weeks.
  • You are known to be allergic to any of the ingredients in the study drug, GI-102.

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: Nari Yun, PhD, GI Innovation, Inc.

Phone: +82-2-404-2003

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
GI Innovation, Inc.
Registry
ClinicalTrials.gov
Start date
30 May 2023
Est. completion
12 November 2025

Where this trial is recruiting

🇰🇷 South Korea 🇺🇸 United States

Primary endpoints

Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose escalation phase of Part A and B); Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs) (dose escalation phase of Part A and B); Objective Response Rate (ORR) (dose optimization phase of Part A, dose expansion phase of Part B, Part C and D)

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