A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma
NCT ID: NCT05548296
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
353 participants
INTERVENTIONAL
2022-08-29
2027-04-30
Brief Summary
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Detailed Description
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Participants in Arms 1 \& 2 will be allocated into two arms based on prospectively predicted sensitivity to ACR-368 using the OncoSignature® Companion Diagnostic test, as follows:
Arm 1: OncoSignature Positive tumors
Arm 2: OncoSignature Negative tumors
OncoSignature Unselected Cohort (Arm 3):
In Arm 3 participants will not require a biopsy or OncoSignature result.
Participants in Arm 1 will receive ACR-368 as monotherapy. Participants in Arms 2 and 3 will receive ACR-368 with ULDG sensitization. Participants in all arms will be treated until disease progression, unacceptable toxicity or any criterion for stopping the study drug or withdrawal from the trial occurs.
Arms 1 and 2 do not apply to sites in the European Union (EU), which will enroll subjects in Arm 3.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OncoSignature Positive Tumors
ARM 1: Participants with OncoSignature Positive Tumors will enter a Phase 2 Simon 2-Stage Study that will assess the efficacy of ACR-368 as monotherapy.
ACR-368
ACR-368 is an experimental drug
OncoSignature
Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy
OncoSignature Negative Tumors
Arm 2: Participants with OncoSignature Negative Tumors will receive ACR-368 with ULDG sensitization. The Phase 2 Study will assess the efficacy and safety of ACR-368 with ULDG sensitization.
ACR-368
ACR-368 is an experimental drug
Gemcitabine
Sensitization of tumor cells is provided through administration of ULDG
OncoSignature
Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy
OncoSignature Unselected (All-Comers)
Arm 3: Participants who are OncoSignature Unselected will receive ACR-368 with ULDG sensitization. The Phase 2 Study will assess the efficacy and safety of ACR-368 with ULDG sensitization.
ACR-368
ACR-368 is an experimental drug
Gemcitabine
Sensitization of tumor cells is provided through administration of ULDG
Interventions
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ACR-368
ACR-368 is an experimental drug
Gemcitabine
Sensitization of tumor cells is provided through administration of ULDG
OncoSignature
Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 (Grade 3 only), serous, carcinosarcomas, clear-cell carcinoma, and mixed histologies.
Arm 3
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 Arm 3
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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. Participant must be willing to provide an archival tumor tissue block or at least 20 unstained slides, if available.
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.
11. Participant must have adequate organ function at Screening, defined as:
1. Absolute neutrophil count \> 1500 cells/µL without growth factor support within 1 week 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
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 6 months 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
18 Years
FEMALE
No
Sponsors
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GOG Foundation
NETWORK
Acrivon Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Panagiotis Konstantinopoulos, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute (DFCI)
Isabelle Ray-Coquard, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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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
Napoli, , 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
Countries
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Central Contacts
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Facility Contacts
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Theresa Thomas
Role: primary
Stacey Kimbell
Role: primary
Maroof Zafar
Role: primary
Lorna Rodriguez, MD
Role: primary
Linda Nguyen
Role: primary
Victoria Arman
Role: primary
Garrett Crook
Role: backup
Esmerelda Martinez
Role: primary
Mohsin Rangwala
Role: primary
Apinya Vorasaph
Role: primary
Rosa Vazquez
Role: primary
Amelia Hardeman
Role: primary
Evelyn Goya
Role: primary
Wilena Session
Role: primary
Peter Wojtowicz
Role: primary
Hilda Diaz
Role: primary
Amber Kindt
Role: primary
Kendrith Rowland
Role: primary
Cynthia Cruz
Role: primary
Heidi Haugland
Role: primary
Alexander Yates
Role: primary
Amanda Maranto
Role: primary
Eleanor Estes
Role: primary
Robert Morris, MD, PhD
Role: primary
Megan Werner
Role: primary
Lori Cappello, MSN, APN-C, CCRP
Role: primary
Karen Jackson
Role: primary
Karen Estok
Role: primary
Mauline Onsombi
Role: primary
Neha Kumarley
Role: primary
Kelly Mateer
Role: primary
Pamela Mason
Role: primary
Rebecca Wirth
Role: primary
Bonny Lami
Role: primary
Kendall Lewis
Role: primary
Siobhan Guyach
Role: primary
Role: primary
Ashley Johnson
Role: primary
Anjali Raina
Role: primary
Celine Saenz
Role: primary
Alfredo Villalobos-Perez
Role: primary
Melanie Hamilton
Role: primary
Thao Amy Nguyen
Role: primary
Jodie Mactagone
Role: primary
Subarna Paul
Role: primary
Related Links
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Related Info
Other Identifiers
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ACR-368-201 (GOG 3082)
Identifier Type: -
Identifier Source: org_study_id
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