Actively Recruiting
A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma
Led by Acrivon Therapeutics · Updated on 2026-05-14
401
Participants Needed
90
Research Sites
274 weeks
Total Duration
On this page
Sponsors
A
Acrivon Therapeutics
Lead Sponsor
G
GOG Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be able to give signed, written informed consent.
- Participant must have histologically documented, high-grade endometrial cancer.
- For Arms 1 and 2: Eligible histological subtypes include all high-grade epithelial endometrial types such as Grade 3 endometrioid, serous, carcinosarcomas, clear-cell carcinoma, mixed histologies, and p53 mutant Grade 2 endometrioid cancer.
- For Arms 3 and 4: Serous carcinoma or mixed tumors with a majority of serous carcinoma or carcinosarcoma where the carcinomatous component is serous carcinoma.
- Subjects in Arms 1 and 2 must have received prior platinum-based chemotherapy and prior anti-PD-(L)1 therapy and no more than three lines of prior systemic therapy.
- Subjects in Arms 3 and 4 must have received prior platinum-based chemotherapy and prior anti-PD-(L)1 therapy and no more than two lines of prior systemic therapy.
- Participant must have histologically confirmed metastatic cancer that progressed during or after at least one prior therapeutic regimen.
- Participant must have at least one measurable lesion per RECIST v1.1 criteria on baseline imaging within 28 days before treatment start and radiographic evidence of disease progression.
- Participants in Arms 1 and 2 must be willing to provide a newly obtained tumor biopsy from an accessible lesion not previously irradiated.
- Participants in Arms 3 and 4 must provide archival tumor tissue as a tissue block or at least 20 unstained slides during or after screening.
- Participant must have recovered or stabilized from prior therapy toxicities to Grade 1 or baseline, with exceptions for alopecia, stable endocrine events, and neuropathy at Grade 2 or less.
- Participant must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Participant must have an estimated life expectancy longer than 3 months.
- Participant must have adequate organ function at screening, including neutrophils >1500 cells/µL, hemoglobin ≥9.0 g/dL, platelets ≥150,000 cells/µL, renal function (GFR ≥50 mL/min/1.73m2), liver enzymes AST and ALT ≤3× ULN or ≤5× ULN if liver metastases present, total bilirubin ≤1.5× ULN or ≤3× ULN if Gilbert's syndrome, and serum albumin ≥3 g/dL.
- Participant must have adequate coagulation profile if not on anticoagulation; if on anticoagulation, must be on a stable dose for ≥1 month with prothrombin time and activated partial thromboplastin time within 1.5× ULN.
You will not qualify if you...
- Participant with symptomatic brain metastases requiring more than 10 mg/day of prednisolone or equivalent.
- Participants with untreated or unstable brain metastases unless recovered from prior treatment and neurologically stable for at least 4 weeks.
- Participant has mesenchymal tumors of the uterus.
- Participant has history of clinically meaningful ascites requiring therapeutic paracentesis or thoracentesis within 4 weeks prior to screening.
- Participants planned for therapeutic paracentesis or thoracentesis between screening and first dose are excluded.
- Participant received systemic therapy or radiation within 3 weeks before first study drug dose.
- Participant has uncontrolled HIV, hepatitis B, or hepatitis C infection.
- Participant has history of clinically significant coagulopathy or bleeding disorders.
- Participant has uncontrolled hypertension (>160/90 mmHg) despite medication.
- Participant has significant cardiac conditions including certain arrhythmias, symptomatic heart failure, unstable angina, recent myocardial infarction, or severe cardiovascular disease.
- Participant had major surgery within 4 weeks before screening.
- Participant has experienced bowel obstruction related to current cancer within 4 weeks or shows signs or symptoms of intestinal obstruction.
- Participant has taken prior cell cycle CHK1 inhibitors, including ACR-368.
AI-Screening
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Trial Site Locations
Total: 90 locations
1
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
Completed
2
Alaska Women's Cancer Center
Anchorage, Alaska, United States, 99508
Completed
3
HonorHealth
Phoenix, Arizona, United States, 85016
Actively Recruiting
4
Arizona Oncology Associate, PC- HOPE
Tucson, Arizona, United States, 85711
Active, Not Recruiting
5
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
6
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
7
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
8
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Completed
9
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
10
Hoag Cancer Center
Newport Beach, California, United States, 92663
Actively Recruiting
11
UC Irvine Health
Orange, California, United States, 92868
Completed
12
Stanford Cancer Center
Palo Alto, California, United States, 94304
Actively Recruiting
13
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
14
University of California Los Angeles (UCLA)
Santa Monica, California, United States, 90404
Actively Recruiting
15
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
16
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Completed
17
Florida Gynecologic Oncology/Regional Cancer Center
Fort Myers, Florida, United States, 33905
Completed
18
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
19
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
20
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Completed
21
Northwestern Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
22
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
23
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Actively Recruiting
24
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
25
Ascension St. Vicent Hospital, Inc.
Indianapolis, Indiana, United States, 46260
Actively Recruiting
26
University of Iowa
Iowa City, Iowa, United States, 52252
Actively Recruiting
27
LSU Health Sciences
New Orleans, Louisiana, United States, 70112
Actively Recruiting
28
Trials365, LLC
Shreveport, Louisiana, United States, 71103
Actively Recruiting
29
American Oncology Partners of Maryland PA
Bethesda, Maryland, United States, 20817
Completed
30
National Institutes of Health, Clinical Center
Bethesda, Maryland, United States, 20892
Active, Not Recruiting
31
Holy Cross Hospital
Silver Spring, Maryland, United States, 20910
Completed
32
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
33
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01605
Completed
34
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
35
HCA Midwest
Kansas City, Missouri, United States, 64132
Actively Recruiting
36
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
37
Rutgers Cancer Institute of NJ
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
38
Laura & Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
39
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States, 10032
Completed
40
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
41
Mount Sinai Health System
New York, New York, United States, 10128
Actively Recruiting
42
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
43
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Completed
44
FirstHealth of the Carolinas
Pinehurst, North Carolina, United States, 28374
Active, Not Recruiting
45
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Completed
46
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Actively Recruiting
47
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
48
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Completed
49
Ohio State University
Hilliard, Ohio, United States, 43026
Actively Recruiting
50
Stephenson Cancer Center at OU Health
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
51
Oncology Associates of Oregon
Eugene, Oregon, United States, 97401
Completed
52
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
Completed
53
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Active, Not Recruiting
54
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
55
Women & Infants Hospital
Providence, Rhode Island, United States, 02905
Actively Recruiting
56
Sanford Health
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
57
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Completed
58
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Completed
59
Texas Oncology
Fort Worth, Texas, United States, 76104
Completed
60
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
61
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
62
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Actively Recruiting
63
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
64
Swedish Cancer Center
Seattle, Washington, United States, 98104
Actively Recruiting
65
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Completed
66
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
67
Summit Cancer Center
Spokane, Washington, United States, 99208
Completed
68
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States, 98684
Completed
69
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
70
Centre François Baclesse
Caen, France
Actively Recruiting
71
Centre Léon Bérard
Lyon, France
Actively Recruiting
72
Insitute de Cancérologie de l'Ouest
Saint-Herblain, France
Actively Recruiting
73
Institute Gustave Roussy
Villejuif, France
Actively Recruiting
74
KEM | Evang. Kliniken Essen-Mitte
Essen, Germany
Not Yet Recruiting
75
Universitätsklinikum Münster, Klinik für Frauenheilkunde und Geburtshilfe
Münster, Germany
Not Yet Recruiting
76
Universitätsklinikum Ulm, Frauenheilunde und Geburtshilfe
Ulm, Germany
Not Yet Recruiting
77
CRO Aviano
Aviano, Italy
Not Yet Recruiting
78
Istituto Clinico Cannizzaro Catania
Catania, Italy
Not Yet Recruiting
79
Istituto Europeo di Oncologia
Milan, Italy
Not Yet Recruiting
80
Fondazione Pascale Istituto Tumori
Naples, Italy
Not Yet Recruiting
81
Humanitas University
Pieve Emanuele, Italy
Not Yet Recruiting
82
Policlinico Gemelli
Roma, Italy
Not Yet Recruiting
83
Ospedale Mauriziano Torino
Turin, Italy
Not Yet Recruiting
84
Hospital Clínic de Barcelona
Barcelona, Spain
Actively Recruiting
85
Institut Català of Oncology (ICO)
Barcelona, Spain
Not Yet Recruiting
86
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain
Not Yet Recruiting
87
Hospital Universitario 12 de Octubre
Madrid, Spain
Not Yet Recruiting
88
Hospital Universitario La Paz
Madrid, Spain
Not Yet Recruiting
89
Hospital Universitario Ramón y Cajal
Madrid, Spain
Not Yet Recruiting
90
Fundacion Instituto Valenciano de Oncologia (IVO)
Valencia, Spain
Not Yet Recruiting
Research Team
M
Mansoor Raza Mirza, MD
CONTACT
J
Jeanie Tang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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