Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer

This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.

Trial Details

NCT ID
NCT05797831
Phase
PHASE2 / PHASE3
Sponsor
Kartos Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Uterine Cancer
Interventions
  • Navtemadlin
  • Navtemadlin Placebo
Locations (sample)
  • Vallejo, California, United States|38.10409,-122.25664
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Savannah, Georgia, United States|32.08354,-81.09983
  • Hinsdale, Illinois, United States|41.80086,-87.93701
  • Fort Wayne, Indiana, United States|41.1306,-85.12886

Key Eligibility Criteria

  • Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT
  • Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or…
  • Adequate hematologic, hepatic and renal function (within 14 days)

For full eligibility, visit ClinicalTrials.gov.

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