Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
Recruiting now Phase 2/3 NCT05797831
Run by Kartos Therapeutics, Inc. · for 18 and older · Women
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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)
🚫 You may not be able to join if…
- 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)
Where this trial is running
- Kaiser Permanente Center, Vallejo, California, United States
- Northside Hospital, Atlanta, Georgia, United States
- St. Joseph, Savannah, Georgia, United States
- Dr. Sudarshan K. Sharma, Ltd., Hinsdale, Illinois, United States
- Parkview Research Center, Fort Wayne, Indiana, United States
- Indiana University, Indianapolis, Indiana, United States
- Maryland Oncology Hematology, P.A., Silver Spring, Maryland, United States
- Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota, United States
- Washington University School of Medicine, St Louis, Missouri, United States
- Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
- Good Samaritan Hospital Medical Center, West Islip, New York, United States
- FirstHealth Carolinas, Pinehurst, North Carolina, United States
+ 71 more sites.
Who to contact
John Mei · 650-542-0136 · jmei@kartosthera.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05797831.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.