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NCT05797831PHASE2, PHASE3Recruiting

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

Kartos Therapeutics, Inc.

Start Date

7/17/2023

Completion Date

7/1/2027

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 Criteria

Age Range: 18 years to No maximum

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)

Interventions

DRUG

Navtemadlin

DRUG

Navtemadlin Placebo

Interested in This Trial?

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Conditions

Endometrial Cancer

Locations

Kaiser Permanente Center

Vallejo, California 94589

United States

Northside Hospital

Atlanta, Georgia 30342

United States

St. Joseph

Savannah, Georgia 31405

United States

Dr. Sudarshan K. Sharma, Ltd.

Hinsdale, Illinois 60521

United States

Parkview Research Center

Fort Wayne, Indiana 46845

United States

Indiana University

Indianapolis, Indiana 46202

United States

Maryland Oncology Hematology, P.A.

Silver Spring, Maryland 20904

United States

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota 55404

United States

Washington University School of Medicine

St Louis, Missouri 63108

United States

Women's Cancer Center of Nevada

Las Vegas, Nevada 89106

United States

Good Samaritan Hospital Medical Center

West Islip, New York 11795

United States

FirstHealth Carolinas

Pinehurst, North Carolina 28374

United States

OhioHealth Institute

Columbus, Ohio 43214

United States

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma 74146

United States

Oncology Associates of Oregon

Eugene, Oregon 97401

United States

Northwest Cancer Specialists

Portland, Oregon 97227

United States

Texas Oncology-Austin Central

Austin, Texas 78745

United States

Texas Oncology-Fort Worth Cancer Center

Fort Worth, Texas 76104

United States

Texas Oncology-San Antonio Medical Center

San Antonio, Texas 78130

United States

University Hospital Graz, Department of Gynecology and Obstetrics

Graz, 8036

Austria

Medizinische Universität Innsbruck

Innsbruck, 6020

Austria

Medizinische Universität Wien

Vienna, 1090

Austria

Cross Cancer Institute

Edmonton, T6G 1Z2

Canada

CHUM - University of Montreal Hospital Centre

Montreal, H2X 3E4

Canada

Odense University Hospital

Odense, DK-5000

Denmark

Tartu University Hospital

Tartu, 50406

Estonia

Kuopio University Hospital

Kuopio, 70200

Finland

Turku University Hospital

Turku, 20520

Finland

LTD High Technology hospital Medcenter

Batumi, 6000

Georgia

American Hospital Network LLC

Tbilisi, 0102

Georgia

Caucasus Medical Centre

Tbilisi, 0186

Georgia

National Institute of Oncology

Budapest, H-1122

Hungary

University of Debrecen Clinical Center

Debrecen, 4032

Hungary

Rambam Medical Center

Haifa, Rambam Medical Center

Israel

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Sourasky Medical Center

Tel Aviv, 6423906

Israel

A.O. Cannizzaro

Catania, 95126

Italy

IRCCS Istituto Romangolo per lo Studio dei Tumori "Dino Amadori"

Forlì, 47014

Italy

Ospedale Policlinico San Martino

Genoa, 16132

Italy

ASST di Lecco-Ospedale Alessandro Manzoni

Lecco, 23900

Italy

Ospedale San Luca

Lucca, 55100

Italy

Osp. Niguarda

Milan, 20162

Italy

University Hospital of Parma

Parma, 43126

Italy

Ospedale Guglielmo da Saliceto

Piacenza, 29121

Italy

Ospedale di Prato S. Stefano

Prato, 59100

Italy

Ospedale Santa Maria delle Croci

Ravenna, 48121

Italy

"Azienda Unità Sanitaria Locale della Romagna - Hospital ""Infermi"" of Rimini Oncology Department"

Rimini, 47923

Italy

Policlinico Umberto

Rome, 00161

Italy

Ospedale Filippo Del Ponte

Varese, 21110

Italy

Health Sciences Kaunas Clinics

Kaunas, LT-45434

Lithuania

Nation Cancer Institute of Lithuania, Vilnius

Vilnius, LT-08660

Lithuania

Southern Hospital Sorlandet

Kristiansand, 4604

Norway

Oslo University Hospital HF

Oslo, 0379

Norway

Sykehusapotek Nord Tromsø

Tromsø, 9038

Norway

Białostockie Centrum Onkologii

Bialystok, 15-027

Poland

Szpitale Pomorskie

Gdansk, 80-210

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214

Poland

NIO-PIB Oddzial w Gliwicach

Gliwice, 44-102

Poland

Centrum Badań klinicznych Jagiellońskie Centrum Innowacji

Krakow, 31-115

Poland

Siedleckie Centrum Onkologii

Olsztyn, 10-228

Poland

Uniwersytecki Szpital

Poznan, 60-569

Poland

NIO-PIB Klinika Gine-Onk

Warsaw, 02-781

Poland

Lower Silesian Oncology, Pulmonology and Hematology Center, Department of Oncological Gynecology

Wroclaw, 53-413

Poland

Bucharest CF2 Hospital

Bucharest, 012244

Romania

Ovidius Clinical Hospital SRL

Constanța, 905900

Romania

Onco Clinic Consult S.A.

Craiova, 200094

Romania

Oncology Center "Sf. Nectarie"

Craiova, 200542

Romania

Gral Medical S.R.L. - Oncofort Hospital

Piteşti, 110283

Romania

Oncocenter, Oncology Clinic SRL

Timișoara, 300166

Romania

SC Oncomed SRL

Timișoara, 300239

Romania

Institute of Oncology Ljubljana

Ljubljana, 1000

Slovenia

University Clinical Center Maribor

Maribor, 2000

Slovenia

CHUAC (Hospital de Coruña)

A Coruña, 15006

Spain

Hospital del Mar

Barcelona, 08003

Spain

Hospital Galdakao-Usansolo

Galdakao, 48960

Spain

Hospital Universitario de Jaen

Jaén, 23007

Spain

H.G.U. Jerez de la Frontera

Jerez de la Frontera, 11407

Spain

Hospital U Insular de GC

Las Palmas, 35016

Spain

Hospital de Leon

León, 24008

Spain

HCU Santiago de Compostela

Santiago de Compostela, 15706

Spain

Hospital Universitario de Valme

Seville, 41014

Spain

Linkoping University Hospital

Linköping, 581 85

Sweden

Karolinska University Hospital

Stockholm, SE-171 76

Sweden