Tirzepatide in Obesity-Driven Endometrial Cancer

Summary

LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC). This is a pre-operative window clinical study. Endometrial biopsy samples from patients before tirzepatide treatment will be compared to their post-intervention hysterectomy specimens. If archival tissue is unavailable, a fresh biopsy will be taken before tirzepatide treatment. Post-intervention tissue will be collected from the hysterectomy specimen. The hypothesis is that tirzepatide's anti-tumorigenic effects are due to both an improvement in the host's metabolic milieu (indirect effect) and a direct effect on the EC tumor microenvironment via the inter-related pathways of insulin, lipid, and mTOR signaling. Therefore, tirzepatide may be an innovative approach to effectively induce weight loss and inhibit tumor growth in EC, the most obesity-driven of all cancers.

Eligibility

Inclusion Criteria:

* Current diagnosis of endometrioid histology cancer and scheduled to undergo hysterectomy and staging.
* Agree to comply with all required study assessments and visits including internet capabilities.
* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Age ≥ 18 at the time of consent.
* Body mass index of ≥30 kg/m2.
* Presumed clinically early-stage disease (disease confined to uterus only).
* ECOG ≤ 2 or Karnofsky Performance Status of \> 50

Exclusion Criteria:

* Active infection requiring systemic therapy.
* Subject is pregnant or breast feeding.
* Taking any prescription medications or other drugs that may influence metabolism per discretion of investigator.
* Taking a central nervous system stimulant.
* Current psychological conditions that would be incompatible with participation in this study, as determined by investigator.
* Known sensitivities (i.e., urticaria and eczema) to GIP and GLP-1 receptor agonists.
* Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or receiving treatment with insulin.
* Have a history of severe hypoglycemia or not be able to communicate an understanding of hypoglycemic symptoms.

Conditions3

Interventions1

Locations1 site

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