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

RecruitingPhase 2, Phase 3Ages 18 Years - anyFemaleKartos Therapeutics, Inc.
NCT05797831 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * ECOG 0-1 * 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 PR per RECIST V1.1 * Adequate hematologic, hepatic and renal function (within 14 days) Exclusion Criteria: * Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation * Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days) * Indwelling surgical drains * Grade 2 or higher QTc prolongation * History of major organ transplant * History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)
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What it tests

  • Navtemadlin
  • Navtemadlin Placebo
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Where

83 sites
Kaiser Permanente Center
Vallejo, United States
Northside Hospital
Atlanta, United States
St. Joseph
Savannah, United States
Dr. Sudarshan K. Sharma, Ltd.
Hinsdale, United States
Parkview Research Center
Fort Wayne, United States
Indiana University
Indianapolis, United States
Maryland Oncology Hematology, P.A.
Silver Spring, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, United States

…and 75 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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