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

Status
Active
Cancer Type
Unknown Primary
Uterine Cancer
Trial Phase
Phase II
Phase III
Eligibility
18 Years and older, Female
Study Type
Treatment
NCT ID
NCT05797831
Protocol IDs
KRT-232-118 (primary)
NCI-2024-03038
ENGOT en-21
GOG-3089
Study Sponsor
Kartos Therapeutics, Inc.

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.

Eligibility

  1. ECOG 0-1
  2. Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT
  3. 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
  4. Adequate hematologic, hepatic and renal function (within 14 days)
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