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Navtemadlin for maintenance therapy in advanced endometrial cancer

A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy

PHASE2; PHASE3 · Kartos Therapeutics, Inc. · NCT05797831

This study is testing if a new treatment called navtemadlin can help people with advanced endometrial cancer stay in remission after responding to previous chemotherapy.

Quick facts

PhasePHASE2; PHASE3
Study typeInterventional
Enrollment268 (estimated)
Ages18 Years and up
SexFemale
SponsorKartos Therapeutics, Inc. (industry)
Drugs / interventionschemotherapy
Locations83 sites (Vallejo, California and 82 other locations)
Trial IDNCT05797831 on ClinicalTrials.gov

What this trial studies

This study evaluates the use of navtemadlin as a maintenance treatment for patients with advanced or recurrent endometrial cancer who have shown a complete or partial response to prior chemotherapy. The trial is divided into two parts: the first part assesses the safety and efficacy of two different doses of navtemadlin compared to an observational control arm, while the second part compares the selected Phase 3 dose of navtemadlin to a placebo. The goal is to determine the optimal dosing and effectiveness of navtemadlin in prolonging patient responses.

Who should consider this trial

Good fit: Ideal candidates are patients with TP53 wild-type advanced or recurrent endometrial cancer who have completed chemotherapy and achieved a response.

Not a fit: Patients with sarcomas, small-cell carcinomas, or those who have received prior immune or investigational therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new maintenance therapy option that improves outcomes for patients with advanced endometrial cancer.

How similar studies have performed: While there have been studies on maintenance therapies in cancer, the specific use of navtemadlin in this context is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Vallejo, California and 82 other locations

+33 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Endometrial Cancer, navtemadlin

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.