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

Status: Recruiting
Location: See all (69) locations...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant must be able to give signed, written informed consent.

• Participant must have histologically documented, high-grade endometrial cancer.

• Treatment History Requirements:

∙ Subject must have received prior platinum-based chemotherapy

‣ Subject must have received prior anti-PD-(L)1 therapy

• Participant must have histologically confirmed metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen.

• 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.

• 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.

• Participant must be willing to provide an archival tumor tissue block or at least 20 unstained slides, if available.

• Participant must have stabilized or recovered (Grade 1 or baseline) from all prior therapy related toxicities, except as follows:

∙ Alopecia is accepted.

‣ Endocrine events from prior immunotherapy stabilized at ≤ Grade 2 due to need for replacement therapy are accepted (including hypothyroidism, diabetes mellitus, or adrenal insufficiency).

‣ Neuropathy events from prior cytotoxic therapies stabilized at ≤ Grade 2 are accepted.

• Participant must have an Eastern Cooperative Oncology Group Performance Status 0 or 1.

⁃ Participant must have an estimated life expectancy of longer than 3 months.

⁃ Participant must have adequate organ function at Screening, defined as:

• Absolute neutrophil count \> 1500 cells/µL without growth factor support within 1 week prior to obtaining the hematology values at Screening.

∙ Hemoglobin ≥ 9.0 g/dL.

∙ Platelets ≥ 150,000 cells/µL without transfusion within 1 week prior to obtaining the hematology values at Screening.

∙ Calculated creatinine clearance (CrCl) ≥ 50 mL/min as calculated by the Cockcroft-Gault formula.

∙ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); ≤ 5 × ULN if liver metastases are present.

∙ Total bilirubin ≤ 1.5 × ULN not associated with Gilbert's syndrome. If associated with Gilbert's syndrome ≤ 3 x ULN is acceptable.

∙ Serum albumin ≥ 3 g/dL.

⁃ 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:

• Prothrombin time within 1.5 x ULN.

∙ Activated partial thromboplastin time within 1.5 x ULN.

Locations
United States
Alaska
Alaska Women's Cancer Center
COMPLETED
Anchorage
Alabama
University of South Alabama Mitchell Cancer Institute
COMPLETED
Mobile
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Arizona
HonorHealth
RECRUITING
Phoenix
Arizona Oncology Associate, PC- HOPE
RECRUITING
Tucson
California
City of Hope National Medical Center
RECRUITING
Duarte
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
Cedars Sinai Medical Center
RECRUITING
Los Angeles
USC/Norris Comprehensive Cancer Center
COMPLETED
Los Angeles
Hoag Cancer Center
RECRUITING
Newport Beach
UC Irvine Health
ACTIVE_NOT_RECRUITING
Orange
Stanford Cancer Center
RECRUITING
Palo Alto
University of California, Davis Comprehensive Cancer Center
RECRUITING
Sacramento
University of California Los Angeles (UCLA)
RECRUITING
Santa Monica
Colorado
University of Colorado
RECRUITING
Aurora
Connecticut
Yale Cancer Center
COMPLETED
New Haven
Florida
Florida Gynecologic Oncology/Regional Cancer Center
RECRUITING
Fort Myers
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami Beach
Georgia
Emory University
RECRUITING
Atlanta
Northeast Georgia Medical Center
COMPLETED
Gainesville
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Northwestern Medicine
RECRUITING
Chicago
University of Chicago Medicine
RECRUITING
Chicago
University of Illinois Cancer Center
RECRUITING
Chicago
Carle Cancer Center
RECRUITING
Urbana
Indiana
Ascension St. Vicent Hospital, Inc.
RECRUITING
Indianapolis
Louisiana
LSU Health Sciences
RECRUITING
New Orleans
Trials365, LLC
RECRUITING
Shreveport
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
University of Massachusetts Chan Medical School
RECRUITING
Worcester
Maryland
American Oncology Partners of Maryland PA
COMPLETED
Bethesda
National Institutes of Health, Clinical Center
RECRUITING
Bethesda
Holy Cross Hospital
COMPLETED
Silver Spring
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Missouri
HCA Midwest
RECRUITING
Kansas City
North Carolina
University of North Carolina at Chapel Hill
COMPLETED
Chapel Hill
FirstHealth of the Carolinas
RECRUITING
Pinehurst
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
RECRUITING
Hackensack
Rutgers Cancer Institute of NJ
RECRUITING
New Brunswick
New York
Laura & Isaac Perlmutter Cancer Center
RECRUITING
New York
Memorial Sloan-Kettering Cancer Center
RECRUITING
New York
Mount Sinai Health System
RECRUITING
New York
New York Presbyterian Hospital-Columbia University Medical Center
RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
Ohio
Gabrail Cancer Center
COMPLETED
Canton
Miami Valley Hospital South
RECRUITING
Centerville
University of Cincinnati Cancer Center
RECRUITING
Cincinnati
Cleveland Clinic Foundation
COMPLETED
Cleveland
Ohio State University
RECRUITING
Hilliard
Oklahoma
Stephenson Cancer Center at OU Health
RECRUITING
Oklahoma City
Oregon
Oncology Associates of Oregon
ACTIVE_NOT_RECRUITING
Eugene
Oregon Health & Sciences University
ACTIVE_NOT_RECRUITING
Portland
Pennsylvania
Fox Chase Cancer Center
ACTIVE_NOT_RECRUITING
Philadelphia
West Penn Hospital
RECRUITING
Pittsburgh
Rhode Island
Women & Infants Hospital
RECRUITING
Providence
South Dakota
Sanford Health
RECRUITING
Sioux Falls
Texas
Texas Oncology-Dallas Presbyterian Hospital
COMPLETED
Dallas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Texas Oncology
COMPLETED
Fort Worth
University of Texas, MD Anderson Cancer Center
RECRUITING
Houston
Utah
Huntsman Cancer Institute, University of Utah
RECRUITING
Salt Lake City
Virginia
University of Virginia Health System
RECRUITING
Charlottesville
Virginia Commonwealth University
RECRUITING
Richmond
Washington
Fred Hutchinson Cancer Center
COMPLETED
Seattle
Swedish Cancer Center
RECRUITING
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
RECRUITING
Spokane
Summit Cancer Center
COMPLETED
Spokane
Northwest Cancer Specialists, P.C.
COMPLETED
Vancouver
Wisconsin
Froedtert and Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Mansoor Raza Mirza, MD
ACR-368-201ClinicalTrial@acrivon.com
617-207-8976
Backup
Monica Phadnis
ACR-368-201ClinicalTrial@acrivon.com
Time Frame
Start Date: 2022-08-29
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 353
Treatments
Experimental: 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.
Experimental: 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.
Experimental: OncoSignature Unselected (All-Comers)
Arm 3: Participants who are OncoSignature Unselected (i.e. they will not require a newly obtained tumor biopsy or OncoSignature testing) will receive ACR-368 with ULDG sensitization. The Phase 2 Study will assess the efficacy and safety of ACR-368 with ULDG sensitization.
Related Therapeutic Areas
Sponsors
Leads: Acrivon Therapeutics
Collaborators: GOG Foundation

This content was sourced from clinicaltrials.gov

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