drugset / Trial / NCT05797831
Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
Phase 2/3
Recruiting
268 enrolled
Kartos Therapeutics, Inc.
European Network of Gynaecological Oncological Trial Groups (ENGOT) · collabGOG Foundation · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2023-07-17
- Primary completion
- 2025-08
- Completion
- 2027-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Navtemadlin | Small molecule | 180 mg | Oral |
| Subject | Navtemadlin | Small molecule | 240 mg | Oral |