Actively Recruiting
A Phase 2 Study of ACR-368 Therapy in Subjects With Endometrial Cancer
Led by Acrivon Therapeutics ยท Updated on 2026-05-14
401
Participants Needed
90
Research Sites
26 weeks
Total Duration
On this page
Sponsors
A
Acrivon Therapeutics
Lead Sponsor
G
GOG Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of ACR-368, an experimental drug, as a monotherapy or combined with ultra-low dose gemcitabine (ULDG) in participants with high-grade endometrial cancer. This open-label Phase 2 study divides participants into groups based on tumor sensitivity predicted by the OncoSignature Companion Diagnostic test or without requiring this test. The study aims to assess the anti-tumor activity of ACR-368 alone or with ULDG in different participant cohorts. Participants are assigned to one of four arms: Arm 1 and Arm 4 receive ACR-368 alone, while Arm 2 and Arm 3 receive ACR-368 with ULDG sensitization. Arms 1 and 2 include participants selected based on OncoSignature results, while Arms 3 and 4 include those without this selection. Treatment continues until disease progression, unacceptable side effects, or withdrawal. European Union sites only enroll participants in Arms 3 and 4. Participants will be monitored every 8 weeks for tumor response using imaging for up to 2 years or until death. Safety assessments, including tracking of adverse events and pharmacokinetic testing, will be conducted throughout. Additional outcomes like overall survival, duration of response, and progression-free survival are evaluated. Participants must provide tumor tissue samples as required, and their organ function and general health will be assessed before and during the study.
CONDITIONS
Brief Title
A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed, written informed consent
- Histologically confirmed high-grade endometrial cancer
- For Arms 1 and 2: high-grade epithelial subtypes including Grade 3 endometrioid, serous, carcinosarcoma, clear-cell, mixed histologies, and p53 mutant Grade 2 endometrioid
- For Arms 3 and 4: serous carcinoma or mixed tumors with majority serous carcinoma or carcinosarcoma
- Prior platinum-based chemotherapy and anti-PD-(L)1 therapy received
- No more than three lines of prior systemic therapy for Arms 1 and 2, no more than two for Arms 3 and 4
- Metastatic cancer progressed during or after at least one prior therapy
- At least one measurable lesion per RECIST v1.1 criteria with recent imaging within 28 days
- Willingness to provide tumor tissue biopsy for Arms 1 and 2; archival tumor tissue for Arms 3 and 4
- Stabilized or recovered from prior therapy toxicities except alopecia and certain endocrine or neuropathy events
- ECOG performance status 0 or 1
- Estimated life expectancy over 3 months
- Adequate organ function including neutrophil count, hemoglobin, platelets, renal function, liver enzymes, bilirubin, and albumin
- Adequate coagulation profile or stable anticoagulation therapy for at least 1 month
You will not qualify if you...
- Symptomatic brain metastases requiring >10 mg/day prednisolone unless treated and stable
- Mesenchymal tumors of the uterus
- Recent history (within 4 weeks) of clinically meaningful ascites requiring paracentesis or thoracentesis
- Systemic or radiation therapy within 3 weeks prior to study drug
- Uncontrolled HIV, hepatitis B, or hepatitis C infection
- History of clinically meaningful coagulopathy or bleeding diathesis
- Cardiovascular disease including uncontrolled hypertension, significant ECG abnormalities, symptomatic heart failure, unstable angina, myocardial infarction, or severe cardiovascular disease
- Major surgery within 4 weeks prior to screening
- Recent bowel obstruction related to cancer within 4 weeks or signs of intestinal obstruction
- Prior treatment with cell cycle CHK1 inhibitors, including ACR-368
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or withdrawal
Participants receive ACR-368 as monotherapy or with ULDG sensitization depending on their tumor status. Treatment continues until disease progression, unacceptable toxicity, or withdrawal from the trial.
Response and safety assessments every 8 weeks from baseline through up to 2 years
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 Franรงois Baclesse
Caen, France
Actively Recruiting
71
Centre Lรฉon Bรฉrard
Lyon, France
Actively Recruiting
72
Insitute de Cancรฉrologie 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
Universitรคtsklinikum Mรผnster, Klinik fรผr Frauenheilkunde und Geburtshilfe
Mรผnster, Germany
Not Yet Recruiting
76
Universitรคtsklinikum 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 Clรญnic de Barcelona
Barcelona, Spain
Actively Recruiting
85
Institut Catalร 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 Ramรณn 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
J
Jeanie Tang
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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