RECRUITING

A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma

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Conditions

Endometrial AdenocarcinomaEndometrial CancerEndometrial NeoplasmUltralow dose gemcitabineACR-368

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-08-29
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05548296

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participant must be able to give signed, written informed consent.
  2. 2. Participant must have histologically documented, high-grade endometrial cancer.
  3. 3. Treatment History Requirements:
  4. 1. Subject must have received prior platinum-based chemotherapy
  5. 2. Subject must have received prior anti-PD-(L)1 therapy
  6. 4. Participant must have histologically confirmed metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen.
  7. 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.
  8. 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.
  9. 7. Participant must be willing to provide an archival tumor tissue block or at least 20 unstained slides, if available.
  10. 8. Participant must have stabilized or recovered (Grade 1 or baseline) from all prior therapy related toxicities, except as follows:
  11. 1. Alopecia is accepted.
  12. 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).
  13. 3. Neuropathy events from prior cytotoxic therapies stabilized at ≤ Grade 2 are accepted.
  14. 9. Participant must have an Eastern Cooperative Oncology Group Performance Status 0 or 1.
  15. 10. Participant must have an estimated life expectancy of longer than 3 months.
  16. 11. Participant must have adequate organ function at Screening, defined as:
  17. 1. Absolute neutrophil count \> 1500 cells/µL without growth factor support within 1 week prior to obtaining the hematology values at Screening.
  18. 2. Hemoglobin ≥ 9.0 g/dL.
  19. 3. Platelets ≥ 150,000 cells/µL without transfusion within 1 week prior to obtaining the hematology values at Screening.
  20. 4. Calculated creatinine clearance (CrCl) ≥ 50 mL/min as calculated by the Cockcroft-Gault formula.
  21. 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); ≤ 5 × ULN if liver metastases are present.
  22. 6. Total bilirubin ≤ 1.5 × ULN not associated with Gilbert's syndrome. If associated with Gilbert's syndrome ≤ 3 x ULN is acceptable.
  23. 7. Serum albumin ≥ 3 g/dL.
  24. 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:
  25. 1. Prothrombin time within 1.5 x ULN.
  26. 2. Activated partial thromboplastin time within 1.5 x ULN.
  1. 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. 2. Participant has mesenchymal tumors of the uterus.
  3. 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. 4. Participant had systemic therapy or radiation therapy within 3 weeks prior to the first dose of study drug.
  5. 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. 6. Participant has a history of clinically meaningful coagulopathy, bleeding diathesis.
  7. 7. Participant has cardiovascular disease, defined as:
  8. 1. Uncontrolled hypertension defined as blood pressure \> 160/90 mmHg at Screening confirmed by repeat (medication permitted).
  9. 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).
  10. 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).
  11. 8. Participant has a history of major surgery within 4 weeks of Screening.
  12. 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.
  13. 10. Participant has taken a prior cell cycle CHK1 inhibitor, including ACR-368

Contacts and Locations

Study Contact

Mansoor Raza Mirza, MD
CONTACT
617-207-8976
ACR-368-201ClinicalTrial@acrivon.com
Monica Phadnis
CONTACT
ACR-368-201ClinicalTrial@acrivon.com

Principal Investigator

Jung-Min Lee, MD
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Panagiotis Konstantinopoulos, MD
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute (DFCI)

Study Locations (Sites)

University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604
United States
Alaska Women's Cancer Center
Anchorage, Alaska, 99508
United States
HonorHealth
Phoenix, Arizona, 85016
United States
Arizona Oncology Associate, PC- HOPE
Tucson, Arizona, 85711
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
City of Hope National Medical Center
Duarte, California, 91010
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92037
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Hoag Cancer Center
Newport Beach, California, 92663
United States
UC Irvine Health
Orange, California, 92868
United States
Stanford Cancer Center
Palo Alto, California, 94304
United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
University of California Los Angeles (UCLA)
Santa Monica, California, 90404
United States
University of Colorado
Aurora, Colorado, 80045
United States
Yale Cancer Center
New Haven, Connecticut, 06520
United States
Florida Gynecologic Oncology/Regional Cancer Center
Fort Myers, Florida, 33905
United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
United States
Emory University
Atlanta, Georgia, 30322
United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
United States
Northwestern Medicine
Chicago, Illinois, 60611
United States
University of Illinois Cancer Center
Chicago, Illinois, 60612
United States
University of Chicago Medicine
Chicago, Illinois, 60637
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
University of Iowa
Iowa City, Iowa, 52252
United States
LSU Health Sciences
New Orleans, Louisiana, 70112
United States
Trials365, LLC
Shreveport, Louisiana, 71103
United States
American Oncology Partners of Maryland PA
Bethesda, Maryland, 20817
United States
National Institutes of Health, Clinical Center
Bethesda, Maryland, 20892
United States
Holy Cross Hospital
Silver Spring, Maryland, 20910
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01605
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
HCA Midwest
Kansas City, Missouri, 64132
United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Rutgers Cancer Institute of NJ
New Brunswick, New Jersey, 08903
United States
Laura & Isaac Perlmutter Cancer Center
New York, New York, 10016
United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, 10032
United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
United States
Mount Sinai Health System
New York, New York, 10128
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
FirstHealth of the Carolinas
Pinehurst, North Carolina, 28374
United States
Gabrail Cancer Center
Canton, Ohio, 44718
United States
Miami Valley Hospital South
Centerville, Ohio, 45459
United States
University of Cincinnati Cancer Center
Cincinnati, Ohio, 45267
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Ohio State University
Hilliard, Ohio, 43026
United States
Stephenson Cancer Center at OU Health
Oklahoma City, Oklahoma, 73104
United States
Oncology Associates of Oregon
Eugene, Oregon, 97401
United States
Oregon Health & Sciences University
Portland, Oregon, 97239
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
West Penn Hospital
Pittsburg, Pennsylvania, 15224
United States
Women & Infants Hospital
Providence, Rhode Island, 02905
United States
Sanford Health
Sioux Falls, South Dakota, 57104
United States
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, 75231
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Texas Oncology
Fort Worth, Texas, 76104
United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
United States
University of Virginia Health System
Charlottesville, Virginia, 22903
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States
Swedish Cancer Center
Seattle, Washington, 98104
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
United States
Summit Cancer Center
Spokane, Washington, 99208
United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
United States
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Acrivon Therapeutics

  • Jung-Min Lee, MD, PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)
  • Panagiotis Konstantinopoulos, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute (DFCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-29
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2022-08-29
Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

  • Endometrial Cancer
  • Endometrial Neoplasm
  • Ultralow dose gemcitabine
  • ACR-368

Additional Relevant MeSH Terms

  • Endometrial Adenocarcinoma