Study on the Safety and Effectiveness of GI-102 for Patients with Advanced Solid Tumors

Sponsor: GI Innovation, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05824975

Provider View

This clinical trial is testing a new treatment called GI-102 to see if it is safe and effective for people with advanced solid tumors. The study will look at how the drug works in the body and its potential benefits.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new drug, GI-102, in treating advanced solid tumors. It will be conducted in two phases: the first phase will determine the best dose of GI-102, and the second phase will expand the study to more patients to further assess its effects. GI-102 is a unique protein designed to target cancer and immune cells, potentially enhancing the body's ability to fight tumors.

Description

This clinical trial is in its early stages (Phase 1/2a) and is open-label, meaning both the researchers and participants know what treatment is being given. The study will test different doses of GI-102 to find the safest and most effective amount. GI-102 is a new type of protein that targets specific cells in the body to help fight cancer. It works by interacting with certain proteins on cancer and immune cells, potentially boosting the immune system's response to tumors. The study may also explore combining GI-102 with other treatments in the future. Participants will receive GI-102 alone in this trial, and researchers will monitor their health and the drug's effects closely.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Must have good organ and bone marrow function.
  • Have a measurable tumor as per standard criteria.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Any side effects from previous cancer treatments must have improved to mild levels, except for hair loss and moderate nerve damage.
  • HIV-positive patients must be on treatment and have well-controlled HIV.

Exclusion Criteria

  • Have active cancer spread to the brain or spinal cord.
  • Have another active cancer.
  • Have active or past Hepatitis B or C infection.
  • Have active or past tuberculosis.
  • Have active or severe infections within the last 4 weeks.
  • Have chronic liver disease or liver scarring, except for liver metastasis.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have had previous treatments similar to GI-102.
  • Have an immune deficiency or are on immune-suppressing medications recently.
  • Have had cancer treatments or investigational drugs within the last 4 weeks.
  • Have had radiation therapy within the last 2 weeks, except for limited palliative treatment.
  • Have received a live vaccine within the last 4 weeks.
  • Have allergies to any components of GI-102.

Other criteria may apply.

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