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New cancer drug GI-108 enters human trials for advanced tumors

NCT ID NCT07172802

Disease control Sponsor: GI Innovation, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tests a new drug called GI-108 in people with advanced or metastatic solid tumors, including lung, head and neck, pancreatic, and kidney cancers. The drug is designed to boost the immune system's ability to fight cancer. The trial will first find the safest dose, then test how well it works in a larger group. About 76 participants will receive the drug intravenously every three weeks for up to two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GI-108 (a bispecific fusion protein targeting CD73 and IL-2)
What this could lead to
If successful, this could lead to a new treatment option for several advanced cancers, potentially shrinking tumors or slowing disease progression.
What could go wrong
This is an early-phase trial with only 76 participants, so safety and effectiveness are not yet proven. The drug may cause immune-related side effects or fail to show meaningful anti-tumor activity.
Why investors are watching

GI Innovation is a micro-cap company, so its value rests heavily on a single early-stage drug. This Phase 1/2 trial tests GI-108, a bispecific fusion protein, alone in 102 patients with advanced or metastatic solid tumors, and measures safety, tolerability, pharmacokinetics, and anti-tumor activity. Because the company is small, this readout can shape whether the drug moves forward and whether partners or investors stay interested.

If it works: If GI-108 shows acceptable safety and signs of tumor control, the company may attract a partner or raise money to run larger trials. That could extend the drug's development and give the company a second program to lean on.

If it fails: If GI-108 causes serious side effects or fails to control tumors, the company may have to slow or stop the program. Early-phase oncology trials often fail, and a micro-cap company has few other assets to fall back on.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 102 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatoryguidelines) at the time of screening. * Has adequate organ and marrow function as defined in protocol. * Measurable disease as per RECIST v1.1. * ECOG performance status 0-1. * Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy,other prior systemic anti-cancer therapy, or surgery must have resolved to Grade≤1, except alopecia and Grade 2 peripheral neuropathy. * HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease as defined in protocol. Key Exclusion Criteria: * Has known active CNS metastases and/or carcinomatous meningitis. An active second malignancy. * Has active or a known history of Hepatitis B or known active Hepatitis C virus infection. * Has active tuberculosis or has a known history of active tuberculosis. Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration. * History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis. * Has an active autoimmune disease that has required systemic treatment in past 2 years. * Previous immunotherapies related to mode of action of GI-102. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroidtherapy or any other form of immunosuppressive medications within 2 weeksprior to Cycle 1 Day 1.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma malignant pancreatic neoplasm metastatic malignant neoplasm neoplasm Neoplasm Metastasis non-small cell lung carcinoma pancreatic neoplasm renal cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Head and neck (HNSCC) Metastatic solid tumor Non-small cell lung cancer (NSCLC) Pancreatic cancer Renal cell carcinoma (RCC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Yonsei University Health System, Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

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