Study on the Safety and Tolerability of GIM-122 in Adults with Advanced Solid Tumors

Sponsor: Georgiamune Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06028074

Provider View

This clinical trial is testing a new drug called GIM-122 to see if it is safe and well-tolerated in adults with advanced solid tumors. The study will also look at how the drug behaves in the body and its potential effectiveness against cancer.

Patient Parameters

Program Overview

The study is investigating a new treatment, GIM-122, which is a type of antibody designed to target cancer cells. The trial is in two parts: the first part will determine the safest dose, and the second part will explore how well the drug works in treating advanced solid tumors. Participants will receive the drug through an IV and will be monitored for safety and any effects on their cancer.

Description

This clinical trial is a Phase 1/2 study, meaning it is in the early stages of testing a new drug called GIM-122. The study is open-label, which means both the researchers and participants know what treatment is being given. It is the first time this drug is being tested in humans. The trial will take place at multiple centers and will involve increasing doses to find the safest and most effective dose. The study is divided into two parts: Part A will focus on finding the right dose and Part B will expand to include more participants to further test the drug's effectiveness. Participants will receive GIM-122 as a single treatment and will be closely monitored for safety, how the drug moves and changes in the body, and any signs of cancer reduction.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Must be in good general health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have acceptable heart, kidney, and liver function based on lab tests done within 28 days before joining the study.
  • Must agree to use two methods of birth control for 90 days after treatment.
  • Must have a confirmed diagnosis of advanced or metastatic solid tumor.
  • Must have previously received treatment with PD-1 or PD-L1 inhibitors and have not responded, or the cancer has returned or progressed.
  • Must have measurable cancer according to specific criteria.
  • Must have tried other checkpoint inhibitors if they did not cause treatment to stop.
  • No other treatment options available.

Exclusion Criteria

  • Currently participating in another clinical trial or receiving other cancer treatments.
  • Women who are pregnant or breastfeeding.
  • History of heart problems, blood clots in the lungs, or significant infections within 6 months before starting the study.
  • Cannot undergo certain imaging tests or other study procedures due to medical or social reasons.
  • Have another type of cancer at a different site.
  • Have cancer that has spread to the brain or spinal cord.
  • Have ongoing side effects from previous treatments that are more than mild.
  • Have had major surgery within a month before starting the study.
  • Have received radiation therapy within two weeks before starting the study.
  • Have had or are planning to have an organ transplant.
  • Have received certain cancer treatments within two to four weeks before starting the study.
  • Have a weakened immune system or are taking medications that suppress the immune system.
  • Have a history of autoimmune diseases like ulcerative colitis or Crohn's disease.
  • Have severe allergies to similar drugs or components of the study medication.
  • Have received live vaccines within 30 days before starting the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.