RecruitingPhase 2NCT05548296

A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma

A Phase 2 Study of ACR-368 Therapy in Subjects With Endometrial Cancer

Sponsor

Acrivon Therapeutics

Enrollment

353 participants

Start Date

Aug 29, 2022

Study Type

INTERVENTIONAL

Conditions

Endometrial Adenocarcinoma

Summary

This is an open label Phase 2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or with ultra-low dose gemcitabine (ULDG) sensitization in participants with endometrial cancer.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called ACR-368 in women with high-grade endometrial cancer (cancer of the uterine lining) that has come back or progressed after prior treatment. ACR-368 targets a protein that helps cancer cells repair DNA damage. **You may be eligible if...** - You have been diagnosed with high-grade endometrial cancer (such as serous, grade 3 endometrioid, clear-cell, or carcinosarcoma) - You have received prior platinum-based chemotherapy and prior immunotherapy (anti-PD-1/PD-L1) - You have not had more than three prior lines of treatment - You have measurable disease (a tumor that can be measured on a scan) - You are in generally good health (ECOG 0–2) **You may NOT be eligible if...** - You have low-grade or other non-qualifying endometrial cancer subtypes - You have had more than three prior chemotherapy regimens - You have active brain metastases - You are pregnant or breastfeeding - You have significant heart, liver, or kidney problems 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.

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Interventions

DRUGACR-368

ACR-368 is an experimental drug

DRUGGemcitabine

Sensitization of tumor cells is provided through administration of ULDG

DIAGNOSTIC_TESTOncoSignature

Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy

Locations(90)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Alaska Women's Cancer Center

Anchorage, Alaska, United States

HonorHealth

Phoenix, Arizona, United States

Arizona Oncology Associate, PC- HOPE

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

City of Hope National Medical Center

Duarte, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Hoag Cancer Center

Newport Beach, California, United States

UC Irvine Health

Orange, California, United States

Stanford Cancer Center

Palo Alto, California, United States

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States

University of California Los Angeles (UCLA)

Santa Monica, California, United States

University of Colorado

Aurora, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Florida Gynecologic Oncology/Regional Cancer Center

Fort Myers, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Emory University

Atlanta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Northwestern Medicine

Chicago, Illinois, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

University of Chicago Medicine

Chicago, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Ascension St. Vicent Hospital, Inc.

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

LSU Health Sciences

New Orleans, Louisiana, United States

Trials365, LLC

Shreveport, Louisiana, United States

American Oncology Partners of Maryland PA

Bethesda, Maryland, United States

National Institutes of Health, Clinical Center

Bethesda, Maryland, United States

Holy Cross Hospital

Silver Spring, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

HCA Midwest

Kansas City, Missouri, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Rutgers Cancer Institute of NJ

New Brunswick, New Jersey, United States

Laura & Isaac Perlmutter Cancer Center

New York, New York, United States

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Mount Sinai Health System

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

FirstHealth of the Carolinas

Pinehurst, North Carolina, United States

Gabrail Cancer Center

Canton, Ohio, United States

Miami Valley Hospital South

Centerville, Ohio, United States

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University

Hilliard, Ohio, United States

Stephenson Cancer Center at OU Health

Oklahoma City, Oklahoma, United States

Oncology Associates of Oregon

Eugene, Oregon, United States

Oregon Health & Sciences University

Portland, Oregon, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

West Penn Hospital

Pittsburgh, Pennsylvania, United States

Women & Infants Hospital

Providence, Rhode Island, United States

Sanford Health

Sioux Falls, South Dakota, United States

Texas Oncology-Dallas Presbyterian Hospital

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Texas Oncology

Fort Worth, Texas, United States

University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Swedish Cancer Center

Seattle, Washington, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States

Summit Cancer Center

Spokane, Washington, United States

Northwest Cancer Specialists, P.C.

Vancouver, Washington, United States

Froedtert and Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Centre François Baclesse

Caen, France

Centre Léon Bérard

Lyon, France

Insitute de Cancérologie de l'Ouest

Saint-Herblain, France

Institute Gustave Roussy

Villejuif, France

KEM | Evang. Kliniken Essen-Mitte

Essen, Germany

Universitätsklinikum Münster, Klinik für Frauenheilkunde und Geburtshilfe

Münster, Germany

Universitätsklinikum Ulm, Frauenheilunde und Geburtshilfe

Ulm, Germany

CRO Aviano

Aviano, Italy

Istituto Clinico Cannizzaro Catania

Catania, Italy

Istituto Europeo di Oncologia

Milan, Italy

Fondazione Pascale Istituto Tumori

Naples, Italy

Humanitas University

Pieve Emanuele, Italy

Policlinico Gemelli

Roma, Italy

Ospedale Mauriziano Torino

Turin, Italy

Hospital Clínic de Barcelona

Barcelona, Spain

Institut Català of Oncology (ICO)

Barcelona, Spain

Vall d'Hebron Institute of Oncology (VHIO)

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Fundacion Instituto Valenciano de Oncologia (IVO)

Valencia, Spain

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NCT05548296

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