A Phase 1/2, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of GIM-531 as a Single Agent and in Combination with Anti-PD-1 in Advanced Solid Tum

Clinical Trial Details

This clinical trial is for adults who have been diagnosed with advanced stage cancer.

The purpose of this study is to determine if the investigational drug GIM-531 is safe and whether it can help a participant’s immune system attack and kill cancer cells, or if the addition of GIM-531 to their anti-PD-1 therapy can help this drug work better to kill cancer cells.

“Investigational” means that GIM-531 has not been approved for use in humans by the United States Food and Drug Administration (FDA).

This study has two parts called Phase 1 and Phase 2:

Phase 1 is a dose escalation phase and will include a limited number of participants with advanced solid tumors to evaluate various dose levels of GIM-531. The dose a participant is assigned will depend on when they are enrolled in the study. Once a dose level is selected based on the early safety, drug behavior, and effectiveness data from a small number of participants in Phase 1, additional participants will be enrolled to evaluate the dose level further in Phase 1 Dose Expansion. Phase 1 Dose Expansion will include four groups based on cancer type: advanced non-small cell lung cancer, advanced triple-negative breast cancer, advanced ovarian cancer, or advanced cancers with a specific genetic mutation (AKT3).
Phase 2 will enroll participants with advanced metastatic melanoma, non-small cell lung cancer and renal cell carcinoma based on the doses used in the Phase 1. In Phase 2, GIM-531 will be given in combination with anti-PD-1 treatment that participants will already be taking. Anti-PD-1 treatment is a type of immunotherapy that works with the immune system to help the body find and destroy cancer cells more effectively.

GIM-531 is given in a soft gel pill form taken by mouth once daily.

Participation in this research may be up to 24 months from beginning to end. This time frame includes screening (up to 28 days), treatment (up to approximately 12 months or 19 visits), and follow up (approximately 12 months or 2 visits and 10 telephone follow-up calls).

Key Eligibility:

Participants must be 18 years of age or older.
Participants must have a cytologically or histologically confirmed locally advanced or metastatic solid tumor that has progressed on standard therapy or for which no standard therapy exists; or be intolerant of standard therapy.

Detailed eligibility reviewed when participant contacts the study team.

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