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

Purpose

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.

Condition

  • Endometrial Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 Arm 1 		Navtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
  • Drug: Navtemadlin
    Navtemadlin is an experimental MDM2 anticancer drug taken by mouth
    Other names:
    • KRT-232
Experimental
Part 1 Arm 2 		Navtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
  • Drug: Navtemadlin
    Navtemadlin is an experimental MDM2 anticancer drug taken by mouth
    Other names:
    • KRT-232
No Intervention
Part 1 Arm 3 		Observational control ("watch and wait") on a 28-day cycle.
Experimental
Part 2 Arm A 		Navtemadlin administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
  • Drug: Navtemadlin
    Navtemadlin is an experimental MDM2 anticancer drug taken by mouth
    Other names:
    • KRT-232
Experimental
Part 2 Arm B 		Navtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
  • Drug: Navtemadlin
    Navtemadlin is an experimental MDM2 anticancer drug taken by mouth
    Other names:
    • KRT-232
Placebo Comparator
Part 2 Arm C 		Placebo administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
  • Drug: Navtemadlin Placebo
    Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth
Placebo Comparator
Part 2 Arm D 		Placebo administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
  • Drug: Navtemadlin Placebo
    Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth

Recruiting Locations

Kaiser Permanente Center
Vallejo, California 94589

Northside Hospital
Atlanta, Georgia 30342

St. Joseph
Savannah, Georgia 31405

Dr. Sudarshan K. Sharma, Ltd.
Hinsdale, Illinois 60521

Parkview Research Center
Fort Wayne, Indiana 46845

Indiana University
Indianapolis, Indiana 46202

Maryland Oncology Hematology, P.A.
Silver Spring, Maryland 20904

Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota 55404

Washington University School of Medicine
St Louis, Missouri 63108

Women's Cancer Center of Nevada
Las Vegas, Nevada 89106

Good Samaritan Hospital Medical Center
West Islip, New York 11795

FirstHealth Carolinas
Pinehurst, North Carolina 28374

OhioHealth Institute
Columbus, Ohio 43214

Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma 74146

Oncology Associates of Oregon
Eugene, Oregon 97401

Northwest Cancer Specialists
Portland, Oregon 97227

Texas Oncology-Austin Central
Austin, Texas 78745

Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas 76104

Texas Oncology-San Antonio Medical Center
San Antonio, Texas 78130

More Details

Status
Recruiting
Sponsor
Kartos Therapeutics, Inc.

Study Contact

John Mei
650-542-0136
jmei@kartosthera.com