Study on Navtemadlin as Maintenance Therapy for Advanced or Recurrent Endometrial Cancer

Sponsor: Kartos Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05797831

Provider View

This clinical trial is testing the drug navtemadlin as a maintenance treatment for patients with advanced or recurrent endometrial cancer who have responded well to chemotherapy. The study will be conducted in two parts to determine the best dose and compare its effectiveness to a placebo.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of navtemadlin as a maintenance treatment for patients with advanced or recurrent endometrial cancer who have shown a complete or partial response to chemotherapy. The study will be conducted in two phases. In the first phase, researchers will test two different doses of navtemadlin to determine the best dose for further testing. In the second phase, the chosen dose will be compared to a placebo to assess its effectiveness and safety.

Eligibility Criteria

Inclusion Criteria

  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have a confirmed diagnosis of endometrial cancer that is TP53WT (a specific genetic marker).
  • Have advanced or recurrent cancer and have completed up to 6 cycles of taxane-platinum chemotherapy, achieving a complete or partial response.
  • Have adequate blood, liver, and kidney function as determined by tests within the last 14 days.

Exclusion Criteria

  • Have any sarcomas or small-cell carcinomas with neuroendocrine features.
  • Have received immune therapy, cytokine therapy, or any experimental treatment within the last 28 days.
  • Have surgical drains in place.
  • Have a heart condition known as QTc prolongation at grade 2 or higher.
  • Have a history of major organ transplant.
  • Have a history of bleeding disorders or major bleeding events, including brain hemorrhage, within the last 24 weeks.

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