Study on the Safety and Tolerability of GIM-531 for Advanced Solid Tumors

Sponsor: Georgiamune Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06425926

Provider View

This clinical trial is testing a new oral medication, GIM-531, to see if it is safe and well-tolerated in adults with advanced solid tumors. The study will also explore how the drug works in the body and its potential to reduce tumors.

Patient Parameters

Program Overview

The study is investigating a new drug called GIM-531, which is taken by mouth and is designed to treat advanced solid tumors. GIM-531 works by targeting specific immune cells called regulatory T-cells. The trial will be conducted in two phases: Phase 1 will focus on finding a safe dose of GIM-531, while Phase 2 will test the drug in patients with advanced melanoma that has not responded to previous treatments.

Description

This clinical trial is a first-in-human study of GIM-531, a new drug for treating advanced solid tumors. The study is divided into two phases. In Phase 1, researchers will test different doses of GIM-531 to find the safest dose for patients. Once a safe dose is determined, Phase 2 will begin, focusing on patients with advanced melanoma that has not improved with other treatments. Participants will receive GIM-531 and be monitored for safety, how the drug moves and works in the body, and any early signs of tumor reduction. The study aims to gather important information about the drug's safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Have a confirmed diagnosis of advanced solid tumor that has worsened despite standard treatments or for which no standard treatment exists.
  • Have not taken any experimental drugs within 4 weeks before the study.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have acceptable heart, kidney, and liver function based on recent tests.
  • Agree to provide a tumor sample for analysis.
  • Women must not be pregnant and must use effective birth control during the study and for 7 months after. Men must use barrier contraception and not donate sperm during the study and for 4 months after.
  • Have measurable disease according to specific criteria.

Phase 2 Specific Inclusion Criteria:

  • Have advanced melanoma that has worsened after anti-PD-1 therapy.
  • Be willing to continue anti-PD-1 therapy during the study.

Exclusion Criteria

  • Have ongoing side effects from previous treatments, except for mild hair loss or nerve damage.
  • Have melanoma with a specific BRAF mutation (Phase 2 only).
  • Have untreated or unstable brain metastases.
  • Have serious heart conditions or rhythm problems.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Be taking high doses of steroids or other immune-suppressing drugs.
  • Have active infections like hepatitis B, hepatitis C, or HIV.
  • Have a history of immune system deficiencies.
  • Have taken cancer treatments or live vaccines recently.
  • Have had major surgery recently.
  • Cannot swallow pills or are taking certain medications that affect drug absorption.

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