A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma
Part of paid clinical trials in Mobile, Alabama.
- Sponsor
- Acrivon Therapeutics
- Study ID
- NCT05548296
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Endometrial Adenocarcinoma
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ACR-368 — DRUGACR-368 is an experimental drug
- Gemcitabine — DRUGSensitization of tumor cells is provided through administration of ULDG
- OncoSignature — DIAGNOSTIC_TESTProspective prediction of drug sensitivity based on a pretreatment tumor biopsy
Study Details
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.
Key Dates
- Start date
- Aug 29, 2022
- Status verified
- Jun 2026
- Primary completion
- May 30, 2027
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 350 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: OncoSignature Positive TumorsARM 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 TumorsArm 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 (Serous All-Comers) ACR-368 with ULDGArm 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.
- Experimental: OncoSignature Unselected (Serous All-Comers) ACR-368Arm 4: Participants who are OncoSignature Unselected will receive ACR-368. The Phase 2 Study will assess the efficacy and safety of ACR-368.
Primary Outcome Measure
Arm 1: Anti-tumor activity of ACR-368 in Endometrial cancer subjects that are OncoSignature Positive. [ Time Frame: Response will be assessed every 8 weeks from baseline through 2 years or death. ]
Central Contacts
- Mansoor Raza Mirza, MD617-207-8976
- Jeanie Tang
Locations (69)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | 36604 | - |
| Alaska Women's Cancer Center | Anchorage | Alaska | 99508 | - |
| HonorHealth | Phoenix | Arizona | 85016 | Theresa Thomas Lyndsay Willmott, MD (PRINCIPAL_INVESTIGATOR) |
| Arizona Oncology Associate, PC- HOPE | Tucson | Arizona | 85711 | - |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | Maroof Zafar Heather Williams, MD (PRINCIPAL_INVESTIGATOR) |
| City of Hope National Medical Center | Duarte | California | 91010 | Lorna Rodriguez, MD Mihae Song, MD (PRINCIPAL_INVESTIGATOR) |
| UC San Diego Moores Cancer Center | La Jolla | California | 92037 | Linda Nguyen Ramez Eskander, MD (PRINCIPAL_INVESTIGATOR) |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | Victoria Arman Garrett Crook Emily Pendergast, MD (PRINCIPAL_INVESTIGATOR) |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | - |
| Hoag Cancer Center | Newport Beach | California | 92663 | Esmerelda Martinez Alberto Mendivil, MD (PRINCIPAL_INVESTIGATOR) |
| UC Irvine Health | Orange | California | 92868 | - |
| Stanford Cancer Center | Palo Alto | California | 94304 | Mohsin Rangwala Kirstin Bixel, MD (PRINCIPAL_INVESTIGATOR) |
| University of California, Davis Comprehensive Cancer Center | Sacramento | California | 95817 | Apinya Vorasaph Hui Chen, MD (PRINCIPAL_INVESTIGATOR) |
| University of California Los Angeles (UCLA) | Santa Monica | California | 90404 | Rosa Vazquez Alexandra Drakaki, MD (PRINCIPAL_INVESTIGATOR) |
| University of Colorado | Aurora | Colorado | 80045 | Amelia Hardeman Lindsay Brubaker, MD (PRINCIPAL_INVESTIGATOR) |
| Yale Cancer Center | New Haven | Connecticut | 06520 | - |
| Florida Gynecologic Oncology/Regional Cancer Center | Fort Myers | Florida | 33905 | - |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | Evelyn Goya Brian Slomovitz, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University | Atlanta | Georgia | 30322 | Wilena Session Kristen Starbuck, MD (PRINCIPAL_INVESTIGATOR) |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | - |
| Northwestern Medicine | Chicago | Illinois | 60611 | Peter Wojtowicz Daniela Matei, MD (PRINCIPAL_INVESTIGATOR) |
| University of Chicago Medicine | Chicago | Illinois | 60637 | Amber Kindt John Moroney, MD (PRINCIPAL_INVESTIGATOR) |
| University of Illinois Cancer Center | Chicago | Illinois | 60612 | Hilda Diaz Rajul Kothari, MD (PRINCIPAL_INVESTIGATOR) |
| Carle Cancer Center | Urbana | Illinois | 61801 | Kendrith Rowland Pratima Chalasani, MD (PRINCIPAL_INVESTIGATOR) |
| Ascension St. Vicent Hospital, Inc. | Indianapolis | Indiana | 46260 | Cynthia Cruz Michael Callahan, MD (PRINCIPAL_INVESTIGATOR) |
| University of Iowa | Iowa City | Iowa | 52252 | Heidi Haugland David Bender, MD (PRINCIPAL_INVESTIGATOR) |
| LSU Health Sciences | New Orleans | Louisiana | 70112 | Alexander Yates Amelia Jernigan, MD (PRINCIPAL_INVESTIGATOR) |
| Trials365, LLC | Shreveport | Louisiana | 71103 | Amanda Maranto Destin Black, MD (PRINCIPAL_INVESTIGATOR) |
| American Oncology Partners of Maryland PA | Bethesda | Maryland | 20817 | - |
| National Institutes of Health, Clinical Center | Bethesda | Maryland | 20892 | - |
| Holy Cross Hospital | Silver Spring | Maryland | 20910 | - |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | Eleanor Estes Panagiotis Konstantinopoulos, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01605 | - |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | Robert Morris, MD, PhD Ira Winer, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| HCA Midwest | Kansas City | Missouri | 64132 | Megan Werner Alaa Elbendary, DO (PRINCIPAL_INVESTIGATOR) |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | Lori Cappello, MSN, APN-C, CCRP Donna McNamara, MD (PRINCIPAL_INVESTIGATOR) |
| Rutgers Cancer Institute of NJ | New Brunswick | New Jersey | 08903 | Karen Jackson Aliza Leiser, MD (PRINCIPAL_INVESTIGATOR) |
| Laura & Isaac Perlmutter Cancer Center | New York | New York | 10016 | Karen Estok Bhavana Pothuri, MD (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | Mauline Onsombi Chrisann Kyi, MD (PRINCIPAL_INVESTIGATOR) |
| Mount Sinai Health System | New York | New York | 10128 | Neha Kumarley Stephanie Blank, MD (PRINCIPAL_INVESTIGATOR) |
| New York Presbyterian Hospital-Columbia University Medical Center | New York | New York | 10032 | - |
| University of Rochester Medical Center | Rochester | New York | 14642 | Kelly Mateer Rachael Turner, MD (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | - |
| FirstHealth of the Carolinas | Pinehurst | North Carolina | 28374 | - |
| Gabrail Cancer Center | Canton | Ohio | 44718 | - |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | Rebecca Wirth Michael Guy, MD (PRINCIPAL_INVESTIGATOR) |
| University of Cincinnati Cancer Center | Cincinnati | Ohio | 45267 | Bonny Lami Caroline Billingsley, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | - |
| Ohio State University | Hilliard | Ohio | 43026 | Kendall Lewis David O'Malley, MD (PRINCIPAL_INVESTIGATOR) |
| Stephenson Cancer Center at OU Health | Oklahoma City | Oklahoma | 73104 | Ashley Willy Debra Richardson, MD (PRINCIPAL_INVESTIGATOR) |
| Oncology Associates of Oregon | Eugene | Oregon | 97401 | - |
| Oregon Health & Sciences University | Portland | Oregon | 97239 | - |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | - |
| West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | Siobhan Guyach Eirween Miller, MD (PRINCIPAL_INVESTIGATOR) |
| Women & Infants Hospital | Providence | Rhode Island | 02905 | Cara Mathews, MD (PRINCIPAL_INVESTIGATOR) |
| Sanford Health | Sioux Falls | South Dakota | 57104 | Ashley Johnson Maria Bell, MD (PRINCIPAL_INVESTIGATOR) |
| Texas Oncology-Dallas Presbyterian Hospital | Dallas | Texas | 75231 | - |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | - |
| Texas Oncology | Fort Worth | Texas | 76104 | - |
| University of Texas, MD Anderson Cancer Center | Houston | Texas | 77030 | Anjali Raina Funda Meric-Bernstam, MD (PRINCIPAL_INVESTIGATOR) |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | 84112 | Celine Saenz Theresa Werner, MD (PRINCIPAL_INVESTIGATOR) |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | Alfredo Villalobos-Perez Linda Duska, MD (PRINCIPAL_INVESTIGATOR) |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | - |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | - |
| Swedish Cancer Center | Seattle | Washington | 98104 | Thao Amy Nguyen Fernanda Musa, MD (PRINCIPAL_INVESTIGATOR) |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | Jodie Mactagone Melanie Bergman, MD (PRINCIPAL_INVESTIGATOR) |
| Summit Cancer Center | Spokane | Washington | 99208 | - |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98684 | - |
| Froedtert and Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Subarna Paul William Bradley, MD (PRINCIPAL_INVESTIGATOR) |
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