NCT05797831

Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent 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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 268 (estimated)
• Sponsor: Kartos Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Navtemadlin	Navtemadlin is an experimental MDM2 anticancer drug taken by mouth
DRUG	Navtemadlin Placebo	Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth

Timeline

• Start date: 2023-07-17
• Primary completion: 2025-08-01
• Completion: 2027-07-01
• First posted: 2023-04-04
• Last updated: 2024-05-02

Locations

83 sites across 17 countries: United States, Austria, Canada, Denmark, Estonia, Finland, Georgia, Hungary, Israel, Italy, Lithuania, Norway, Poland, Romania, Slovenia, Spain, Sweden

Regulatory

• FDA-regulated drug study