New drug combo aims to shrink endometrial tumors

NCT ID NCT05548296

Disease control Sponsor: Acrivon Therapeutics Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This Phase 2 trial tests an experimental drug called ACR-368, alone or with a low dose of gemcitabine, in 350 people with high-grade endometrial cancer. A special test (OncoSignature) helps decide which treatment arm a participant joins. The main goal is to see if the drug shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ACR-368 (prexasertib) and ultra-low dose gemcitabine
What this could lead to: If successful, this could provide a new treatment option for people with high-grade endometrial cancer, especially those whose tumors are sensitive based on the OncoSignature test.
What could go wrong: This is a Phase 2 trial, so the drug is still experimental. It may not work for everyone, and side effects are possible. The OncoSignature test is also investigational.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: General 1. Participant must be able to give signed, written informed consent. 2. Participant must have histologically documented, high-grade endometrial cancer. Arms 1 and 2 1. All high-grade epithelial endometrial histological subtypes are eligible including: endometrioid (all Grade 3), serous, carcinosarcomas, clear-cell carcinoma, and mixed histologies. Note: Subjects with p53 mutant Grade 2 endometrioid cancer are eligible Arms 3 and 4 2. Serous carcinoma or mixed tumors with a majority component of serous carcinoma or carcinosarcoma where the carcinomatous component is serous carcinoma. 3. Treatment History Requirements: Arms 1 and 2 1. Subject must have received prior platinum-based chemotherapy 2. Subject must have received prior anti-PD-(L)1 therapy 3. Subject must not have received more than three lines of prior systemic therapy Arms 3 and 4  1. Subject must have received prior platinum-based chemotherapy 2. Subject must have received prior anti-PD-(L)1 therapy 3. Subject must not have received more than two lines of prior systemic therapy 4. Participant must have histologically confirmed metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen. 5. Participant must have at least 1 measurable lesion per RECIST v1.1 criteria (by local Investigator) in a baseline tumor imaging that has been obtained within 28 days of the treatment start. Participant must have radiographic evidence of disease progression based on RECIST v1.1 criteria following the most recent line of treatment. 6. Arm 1 and 2 only: Participant must be willing to provide tissue from a newly obtained tumor biopsy from an accessible tumor lesion not previously irradiated after written informed consent. Newly obtained is defined as a specimen taken after written informed consent is obtained, during the 28-day Screening period. Note: Subjects at EU sites are not eligible for Arm 1 and Arm 2 7. For all subjects participating in Arm 3 and 4, archival tumor tissue must be provided either during or after screening either as a tissue block or at least 20 unstained slides. 8. Participant must have stabilized or recovered (Grade 1 or baseline) from all prior therapy related toxicities, except as follows: 1. Alopecia is accepted. 2. Endocrine events from prior immunotherapy stabilized at ≤ Grade 2 due to need for replacement therapy are accepted (including hypothyroidism, diabetes mellitus, or adrenal insufficiency). 3. Neuropathy events from prior cytotoxic therapies stabilized at ≤ Grade 2 are accepted. 9. Participant must have an Eastern Cooperative Oncology Group Performance Status 0 or 1. 10. Participant must have an estimated life expectancy of longer than 3 months in the clinical judgment of the investigator. 11. Participant must have adequate organ function at Screening, defined as: 1. Absolute neutrophil count \> 1500 cells/µL without growth factor support within 2 weeks prior to obtaining the hematology values at Screening. 2. Hemoglobin ≥ 9.0 g/dL. 3. Platelets ≥ 150,000 cells/µL without transfusion within 1 week prior to obtaining the hematology values at Screening. 4. Renal function is defined as Glomerular filtration rate (GFR) ≥ 50 mL/min/1.73m2. Note: GFR may be estimated using site standard methods (e.g., CKD-EPI, MDRD, or Cockcroft-Gault) or measured using 24-hour urine collection or Chrome-EDTA clearance, as per site standard practice. 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); ≤ 5 × ULN if liver metastases are present. 6. Total bilirubin ≤ 1.5 × ULN not associated with Gilbert's syndrome. If associated with Gilbert's syndrome ≤ 3 x ULN is acceptable. 7. Serum albumin ≥ 3 g/dL. 12. Participant must have adequate coagulation profile as defined below if not on anticoagulation. If subject is receiving anticoagulation therapy, then subject must be on a stable dose of anticoagulation for ≥ 1 month: 1. Prothrombin time within 1.5 x ULN. 2. Activated partial thromboplastin time within 1.5 x ULN. Exclusion Criteria: General 1. Participant with known symptomatic brain metastases requiring \> 10 mg/day of prednisolone (or its equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of ACR-368 treatment, fulfill the steroid requirement for these metastases, and are neurologically stable based on central nervous system imaging ≥ 4 weeks after treatment. 2. Participant has mesenchymal tumors of the uterus. 3. Participant has a history of clinically meaningful ascites, defined as history of paracentesis or thoracentesis with therapeutic intent, within 4 weeks of Screening. Subjects with planned therapeutic paracentesis or thoracentesis between Screening and Cycle 1 Day 1 dosing are excluded. 4. Participant had systemic therapy or radiation therapy within 3 weeks prior to the first dose of study drug. 5. Participants has known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is considered uncontrolled based on the criteria included in Appendix 2. 6. Participant has a history of clinically meaningful coagulopathy, bleeding diathesis. 7. Participant has cardiovascular disease, defined as: 1. Uncontrolled hypertension defined as blood pressure \> 160/90 mmHg at Screening confirmed by repeat (medication permitted). 2. History of torsades de pointes, significant Screening electrocardiogram (ECG) abnormalities, including ventricular rhythm disturbances, unstable cardiac arrhythmia requiring medication, pathologic symptomatic bradycardia, left bundle branch block, second degree atrioventricular (AV) block type II, third degree AV block, Grade ≥ 2 bradycardia, uncorrected hypokalemia not amenable to correction, congenital long QT syndrome, prolonged QT interval due to medications, corrected QT based on Fridericia's formula (QTcF) \> 450 msec (for men) or \> 470 msec (for women). 3. Symptomatic heart failure (per New York Heart Association guidelines; (Caraballo, 2019), unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction \< 20%, transient ischemic attack, or cerebrovascular accident within 6 months of Day 1). 8. Participant has a history of major surgery within 4 weeks of Screening. 9. Participant has experienced bowel obstruction related to the current cancer within the last 4 weeks or signs or symptoms of intestinal obstruction, which include nausea, vomiting, or objective radiologic finding of bowel obstruction in the last 4 weeks before the start of the treatment. 10. Participant has taken a prior cell cycle CHK1 inhibitor, including ACR-368

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrium adenocarcinoma endometrium neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrial adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

63 sites in 5 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

Alaska Women's Cancer Center
COMPLETED

Anchorage, Alaska, 99508, United States
American Oncology Partners of Maryland PA
COMPLETED

Bethesda, Maryland, 20817, United States
Arizona Oncology Associate, PC- HOPE
ACTIVE_NOT_RECRUITING

Tucson, Arizona, 85711, United States
Ascension St. Vicent Hospital, Inc.
RECRUITING

Indianapolis, Indiana, 46260, United States
CRO Aviano
RECRUITING

Aviano, Italy
Carle Cancer Center
RECRUITING

Urbana, Illinois, 61801, United States
Cedars Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Centre François Baclesse
RECRUITING

Caen, France
Centre Léon Bérard
RECRUITING

Lyon, France
City of Hope National Medical Center
RECRUITING

Duarte, California, 91010, United States
Cleveland Clinic Foundation
COMPLETED

Cleveland, Ohio, 44195, United States
Dana Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02115, United States
Emory University
RECRUITING

Atlanta, Georgia, 30322, United States
FirstHealth of the Carolinas
ACTIVE_NOT_RECRUITING

Pinehurst, North Carolina, 28374, United States
Florida Gynecologic Oncology/Regional Cancer Center
COMPLETED

Fort Myers, Florida, 33905, United States
Fondazione Pascale Istituto Tumori
RECRUITING

Naples, Italy
Fox Chase Cancer Center
ACTIVE_NOT_RECRUITING

Philadelphia, Pennsylvania, 19111, United States
Fred Hutchinson Cancer Center
COMPLETED

Seattle, Washington, 98109, United States
Froedtert and Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Fundacion Instituto Valenciano de Oncologia (IVO)
RECRUITING

Valencia, Spain
Gabrail Cancer Center
COMPLETED

Canton, Ohio, 44718, United States
HCA Midwest
RECRUITING

Kansas City, Missouri, 64132, United States
Hoag Cancer Center
RECRUITING

Newport Beach, California, 92663, United States
Holy Cross Hospital
COMPLETED

Silver Spring, Maryland, 20910, United States
HonorHealth
RECRUITING

Phoenix, Arizona, 85016, United States
Hospital Clínic de Barcelona
RECRUITING

Barcelona, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, Spain
Hospital Universitario La Paz
RECRUITING

Madrid, Spain
Hospital Universitario Puerta de Hierro
NOT_YET_RECRUITING

Barcelona, Spain
Hospital Universitario Ramón y Cajal
RECRUITING

Madrid, Spain
Humanitas University
RECRUITING

Pieve Emanuele, Italy
Huntsman Cancer Institute, University of Utah
RECRUITING

Salt Lake City, Utah, 84112, United States
Insitute de Cancérologie de l'Ouest
RECRUITING

Saint-Herblain, France
Institute Gustave Roussy
RECRUITING

Villejuif, France
Istituto Clinico Cannizzaro Catania
RECRUITING

Catania, Italy
Istituto Europeo di Oncologia
RECRUITING

Milan, Italy
John Theurer Cancer Center at Hackensack University Medical Center
RECRUITING

Hackensack, New Jersey, 07601, United States
KEM | Evang. Kliniken Essen-Mitte
NOT_YET_RECRUITING

Essen, Germany
Karmanos Cancer Institute
RECRUITING

Detroit, Michigan, 48201, United States
LSU Health Sciences
RECRUITING

New Orleans, Louisiana, 70112, United States
Laura & Isaac Perlmutter Cancer Center
RECRUITING

New York, New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
Miami Valley Hospital South
RECRUITING

Centerville, Ohio, 45459, United States
Mount Sinai Comprehensive Cancer Center
RECRUITING

Miami Beach, Florida, 33140, United States
Mount Sinai Health System
RECRUITING

New York, New York, 10128, United States
National Institutes of Health, Clinical Center
ACTIVE_NOT_RECRUITING

Bethesda, Maryland, 20892, United States
New York Presbyterian Hospital-Columbia University Medical Center
COMPLETED

New York, New York, 10032, United States
Northeast Georgia Medical Center
COMPLETED

Gainesville, Georgia, 30501, United States
Northwest Cancer Specialists, P.C.
COMPLETED

Vancouver, Washington, 98684, United States
Northwestern Medicine
RECRUITING

Chicago, Illinois, 60611, United States
Ohio State University
RECRUITING

Hilliard, Ohio, 43026, United States
Oncology Associates of Oregon
COMPLETED

Eugene, Oregon, 97401, United States
Oregon Health & Sciences University
COMPLETED

Portland, Oregon, 97239, United States
Ospedale Mauriziano Torino
RECRUITING

Turin, Italy
Policlinico Gemelli
RECRUITING

Roma, Italy
Providence Sacred Heart Medical Center and Children's Hospital
RECRUITING

Spokane, Washington, 99204, United States
Rutgers Cancer Institute of NJ
RECRUITING

New Brunswick, New Jersey, 08903, United States
Sanford Health
RECRUITING

Sioux Falls, South Dakota, 57104, United States
Stanford Cancer Center
RECRUITING

Palo Alto, California, 94304, United States
Stephenson Cancer Center at OU Health
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Summit Cancer Center
COMPLETED

Spokane, Washington, 99208, United States
Swedish Cancer Center
RECRUITING

Seattle, Washington, 98104, United States
Texas Oncology
COMPLETED

Fort Worth, Texas, 76104, United States
Texas Oncology-Dallas Presbyterian Hospital
COMPLETED

Dallas, Texas, 75231, United States
Trials365, LLC
RECRUITING

Shreveport, Louisiana, 71103, United States
UC Irvine Health
COMPLETED

Orange, California, 92868, United States
UC San Diego Moores Cancer Center
RECRUITING

La Jolla, California, 92037, United States
USC/Norris Comprehensive Cancer Center
COMPLETED

Los Angeles, California, 90033, United States
University of Arkansas for Medical Sciences
RECRUITING

Little Rock, Arkansas, 72205, United States
University of California Los Angeles (UCLA)
RECRUITING

Santa Monica, California, 90404, United States
University of California, Davis Comprehensive Cancer Center
RECRUITING

Sacramento, California, 95817, United States
University of Chicago Medicine
RECRUITING

Chicago, Illinois, 60637, United States
University of Cincinnati Cancer Center
RECRUITING

Cincinnati, Ohio, 45267, United States
University of Colorado
RECRUITING

Aurora, Colorado, 80045, United States
University of Illinois Cancer Center
RECRUITING

Chicago, Illinois, 60612, United States
University of Iowa
RECRUITING

Iowa City, Iowa, 52252, United States
University of Massachusetts Chan Medical School
COMPLETED

Worcester, Massachusetts, 01605, United States
University of North Carolina at Chapel Hill
COMPLETED

Chapel Hill, North Carolina, 27599, United States
University of Rochester Medical Center
RECRUITING

Rochester, New York, 14642, United States
University of South Alabama Mitchell Cancer Institute
COMPLETED

Mobile, Alabama, 36604, United States
University of Texas Southwestern Medical Center
COMPLETED

Dallas, Texas, 75390, United States
University of Texas, MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
University of Virginia Health System
RECRUITING

Charlottesville, Virginia, 22903, United States
Universitätsklinikum Münster, Klinik für Frauenheilkunde und Geburtshilfe
NOT_YET_RECRUITING

Münster, Germany
Universitätsklinikum Ulm, Frauenheilunde und Geburtshilfe
NOT_YET_RECRUITING

Ulm, Germany
Vall d'Hebron Institute of Oncology (VHIO)
RECRUITING

Barcelona, Spain
Virginia Commonwealth University
ACTIVE_NOT_RECRUITING

Richmond, Virginia, 23298, United States
West Penn Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15224, United States
Women & Infants Hospital
RECRUITING

Providence, Rhode Island, 02905, United States

Contact Email: •••••@•••••
Yale Cancer Center
COMPLETED

New Haven, Connecticut, 06520, United States

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