RecruitingPhase 2Phase 3NCT05797831

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

A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy

Sponsor

Kartos Therapeutics, Inc.

Enrollment

268 participants

Start Date

Jul 17, 2023

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called navtemadlin as a maintenance therapy — treatment given after initial chemotherapy to prevent cancer from coming back — in patients with advanced or recurrent uterine cancer that has a normal TP53 gene. **You may be eligible if...** - You have confirmed endometrial cancer with a normal TP53 gene (called TP53 wild-type) - Your cancer is advanced or has come back after a single course of taxane-platinum chemotherapy (up to 6 cycles) - You achieved a complete or partial response to that chemotherapy - You have a good performance status (ECOG 0–1) and adequate organ function **You may NOT be eligible if...** - Your tumor is a sarcoma, small-cell carcinoma, or has neuroendocrine features - You have received prior immunotherapy or other investigational treatments recently - You have indwelling surgical drains or Grade 2+ peripheral neuropathy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNavtemadlin

Navtemadlin is an experimental MDM2 anticancer drug taken by mouth

DRUGNavtemadlin Placebo

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

Locations(83)

Kaiser Permanente Center

Vallejo, California, United States

Northside Hospital

Atlanta, Georgia, United States

St. Joseph

Savannah, Georgia, United States

Dr. Sudarshan K. Sharma, Ltd.

Hinsdale, Illinois, United States

Parkview Research Center

Fort Wayne, Indiana, United States

Indiana University

Indianapolis, Indiana, United States

Maryland Oncology Hematology, P.A.

Silver Spring, Maryland, United States

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States

Good Samaritan Hospital Medical Center

West Islip, New York, United States

FirstHealth Carolinas

Pinehurst, North Carolina, United States

OhioHealth Institute

Columbus, Ohio, United States

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, United States

Oncology Associates of Oregon

Eugene, Oregon, United States

Northwest Cancer Specialists

Portland, Oregon, United States

Texas Oncology-Austin Central

Austin, Texas, United States

Texas Oncology-Fort Worth Cancer Center

Fort Worth, Texas, United States

Texas Oncology-San Antonio Medical Center

San Antonio, Texas, United States

University Hospital Graz, Department of Gynecology and Obstetrics

Graz, Austria

Medizinische Universität Innsbruck

Innsbruck, Austria

Medizinische Universität Wien

Vienna, Austria

Cross Cancer Institute

Edmonton, Canada

CHUM - University of Montreal Hospital Centre

Montreal, Canada

Odense University Hospital

Odense, Denmark

Tartu University Hospital

Tartu, Estonia

Kuopio University Hospital

Kuopio, Finland

Turku University Hospital

Turku, Finland

LTD High Technology hospital Medcenter

Batumi, Georgia

American Hospital Network LLC

Tbilisi, Georgia

Caucasus Medical Centre

Tbilisi, Georgia

National Institute of Oncology

Budapest, Hungary

University of Debrecen Clinical Center

Debrecen, Hungary

Rambam Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Sourasky Medical Center

Tel Aviv, Israel

A.O. Cannizzaro

Catania, Italy

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

Forlì, Italy

Ospedale Policlinico San Martino

Genoa, Italy

ASST di Lecco-Ospedale Alessandro Manzoni

Lecco, Italy

Ospedale San Luca

Lucca, Italy

Osp. Niguarda

Milan, Italy

University Hospital of Parma

Parma, Italy

Ospedale Guglielmo da Saliceto

Piacenza, Italy

Ospedale di Prato S. Stefano

Prato, Italy

Ospedale Santa Maria delle Croci

Ravenna, Italy

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

Rimini, Italy

Policlinico Umberto

Rome, Italy

Ospedale Filippo Del Ponte

Varese, Italy

Health Sciences Kaunas Clinics

Kaunas, Lithuania

Nation Cancer Institute of Lithuania, Vilnius

Vilnius, Lithuania

Southern Hospital Sorlandet

Kristiansand, Norway

Oslo University Hospital HF

Oslo, Norway

Sykehusapotek Nord Tromsø

Tromsø, Norway

Białostockie Centrum Onkologii

Bialystok, Poland

Szpitale Pomorskie

Gdansk, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

NIO-PIB Oddzial w Gliwicach

Gliwice, Poland

Centrum Badań klinicznych Jagiellońskie Centrum Innowacji

Krakow, Poland

Siedleckie Centrum Onkologii

Olsztyn, Poland

Uniwersytecki Szpital

Poznan, Poland

NIO-PIB Klinika Gine-Onk

Warsaw, Poland

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

Wroclaw, Poland

Bucharest CF2 Hospital

Bucharest, Romania

Ovidius Clinical Hospital SRL

Constanța, Romania

Onco Clinic Consult S.A.

Craiova, Romania

Oncology Center "Sf. Nectarie"

Craiova, Romania

Gral Medical S.R.L. - Oncofort Hospital

Piteşti, Romania

Oncocenter, Oncology Clinic SRL

Timișoara, Romania

SC Oncomed SRL

Timișoara, Romania

Institute of Oncology Ljubljana

Ljubljana, Slovenia

University Clinical Center Maribor

Maribor, Slovenia

CHUAC (Hospital de Coruña)

A Coruña, Spain

Hospital del Mar

Barcelona, Spain

Hospital Galdakao-Usansolo

Galdakao, Spain

Hospital Universitario de Jaen

Jaén, Spain

H.G.U. Jerez de la Frontera

Jerez de la Frontera, Spain

Hospital U Insular de GC

Las Palmas, Spain

Hospital de Leon

León, Spain

HCU Santiago de Compostela

Santiago de Compostela, Spain

Hospital Universitario de Valme

Seville, Spain

Linkoping University Hospital

Linköping, Sweden

Karolinska University Hospital

Stockholm, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05797831

Related Trials

DESTINY-PANTUMOUR04

NCT0712400017 locations

Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors

NCT0621891418 locations

Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER

NCT05640999105 locations

A Phase 1 Study of the Safety and Tolerability of CTX-10726

NCT074198413 locations

Tirzepatide in Obesity-Driven Endometrial Cancer

NCT070655521 location