Recruiting
Phase 2
Phase 3

Navtemadlin

Sponsor:

Kartos Therapeutics, Inc.

Code:

NCT05797831

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Navtemadlin

Navtemadlin Placebo

Study Details

Brief 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

Study ID

NCT05797831

Start date

Jul 17, 2023

Status verified date

Apr, 2024

Completion date

Jul, 2027

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

268 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 Arm 1

Navtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.

experimental: Part 1 Arm 2

Navtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.

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.

experimental: Part 2 Arm B

Navtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.

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.

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.

Interventions

Navtemadlin

Navtemadlin is an experimental MDM2 anticancer drug taken by mouth

Navtemadlin Placebo

Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth

Primary outcome measure

  • Part 1: To determine the navtemadlin Phase 3 dose [ Time Frame: 12 months ]
  • Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo [ Time Frame: 50 months ]

Central Contacts and Locations

Central contacts

John Mei

650-542-0136jmei@kartosthera.com

Locations

Kaiser Permanente Center

Recruiting

Vallejo, California, United States, 94589

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

St. Joseph

Recruiting

Savannah, Georgia, United States, 31405

Dr. Sudarshan K. Sharma, Ltd.

Recruiting

Hinsdale, Illinois, United States, 60521

Parkview Research Center

Recruiting

Fort Wayne, Indiana, United States, 46845

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Maryland Oncology Hematology, P.A.

Recruiting

Silver Spring, Maryland, United States, 20904

Minnesota Oncology Hematology, P.A.

Recruiting

Minneapolis, Minnesota, United States, 55404

Washington University School of Medicine

Recruiting

Saint Louis, Missouri, United States, 63108

Women's Cancer Center of Nevada

Recruiting

Las Vegas, Nevada, United States, 89106

Good Samaritan Hospital Medical Center

Recruiting

West Islip, New York, United States, 11795

FirstHealth Carolinas

Recruiting

Pinehurst, North Carolina, United States, 28374

OhioHealth Institute

Recruiting

Columbus, Ohio, United States, 43214

Oklahoma Cancer Specialists and Research Institute

Recruiting

Tulsa, Oklahoma, United States, 74146

Oncology Associates of Oregon

Recruiting

Eugene, Oregon, United States, 97401

Northwest Cancer Specialists

Recruiting

Portland, Oregon, United States, 97227

Texas Oncology-Austin Central

Recruiting

Austin, Texas, United States, 78745

Texas Oncology-Fort Worth Cancer Center

Recruiting

Fort Worth, Texas, United States, 76104

Texas Oncology-San Antonio Medical Center

Recruiting

San Antonio, Texas, United States, 78130

Cross Cancer Institute

Recruiting

Edmonton, Canada, T6G 1Z2

CHUM - University of Montreal Hospital Centre

Recruiting

Montreal, Canada, H2X 3E4

More Information

Sponsor

Kartos Therapeutics, Inc.

Last update posted

May 2, 2024

Last verified

Apr, 2024

Keywords

  • navtemadlin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kartos Therapeutics, Inc. on 2024-05-02.