A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma

May 12, 2026 updated by: Acrivon Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

OncoSignature Selected Cohorts (Arms 1 and 2):

Participants in Arms 1 & 2 will be allocated into two arms based on prospectively predicted sensitivity to ACR-368 using the OncoSignature® Companion Diagnostic test, as follows:

Arm 1: OncoSignature Positive tumors

Arm 2: OncoSignature Negative tumors (completed)

OncoSignature Unselected Cohort (Arm 3 & Arm 4):

In Arm 3 and Arm 4, participants will not require a biopsy or OncoSignature result.

Participants in Arm 1 and Arm 4 will receive ACR-368 as monotherapy. Participants in Arms 2 and 3 will receive ACR-368 with ULDG sensitization. Participants in all arms will be treated until disease progression, unacceptable toxicity or any criterion for stopping the study drug or withdrawal from the trial occurs.

Arms 1 and 2 do not apply to sites in the European Union (EU), which will enroll subjects in Arm 3 and Arm 4.

Study Type

Interventional

Enrollment (Estimated)

401

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Caen, France
        • Recruiting
        • Centre Francois Baclesse
        • Principal Investigator:
          • Florence Joly-Lobbedez, MD
      • Lyon, France
        • Recruiting
        • Centre Léon Bérard
        • Principal Investigator:
          • Isabelle Ray-Coquard, MD
      • Saint-Herblain, France
        • Recruiting
        • Insitute de Cancérologie de l'Ouest
        • Principal Investigator:
          • Jean-Sebastien Frenel, MD
      • Villejuif, France
        • Recruiting
        • Institute Gustave Roussy
        • Principal Investigator:
          • Alexandra Leary, MD
  • Germany
      • Essen, Germany
        • Not yet recruiting
        • KEM | Evang. Kliniken Essen-Mitte
        • Principal Investigator:
          • Philipp Harter, MD
      • Münster, Germany
        • Not yet recruiting
        • Universitätsklinikum Münster, Klinik für Frauenheilkunde und Geburtshilfe
        • Principal Investigator:
          • Lars Hanker, MD
      • Ulm, Germany
        • Not yet recruiting
        • Universitätsklinikum Ulm, Frauenheilunde und Geburtshilfe
        • Principal Investigator:
          • Sabine Heublein, MD
  • Italy
      • Aviano, Italy
        • Not yet recruiting
        • CRO Aviano
        • Principal Investigator:
          • Michele Bartoletti, MD
      • Catania, Italy
        • Not yet recruiting
        • Istituto Clinico Cannizzaro Catania
        • Principal Investigator:
          • Giuseppa Scandurra, MD
      • Milan, Italy
        • Not yet recruiting
        • Istituto Europeo di Oncologia
        • Principal Investigator:
          • Nicoletta Colombo, MD
      • Naples, Italy
        • Not yet recruiting
        • Fondazione Pascale Istituto Tumori
        • Principal Investigator:
          • Carmela Pisano, MD
      • Pieve Emanuele, Italy
        • Not yet recruiting
        • Humanitas University
        • Principal Investigator:
          • Domenica Lorusso, MD
      • Roma, Italy
        • Not yet recruiting
        • Policlinico Gemelli
        • Principal Investigator:
          • Anna Fagotti, MD
      • Turin, Italy
        • Not yet recruiting
        • Ospedale Mauriziano Torino
        • Principal Investigator:
          • Giorgio Valabrega, MD
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic de Barcelona
        • Principal Investigator:
          • Lydia Gaba Garcia, MD
      • Barcelona, Spain
        • Not yet recruiting
        • Institut Català of Oncology (ICO)
        • Principal Investigator:
          • Marta Gil-Martin, MD
      • Barcelona, Spain
        • Not yet recruiting
        • Vall d'Hebron Institute of Oncology (VHIO)
        • Principal Investigator:
          • Lorena Farinas, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Luis Manuel Manso Sanchez, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Andrés Redondo Sanchez, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Ramon y Cajal
        • Principal Investigator:
          • Eva María Guerra Alia, MD
      • Valencia, Spain
        • Not yet recruiting
        • Fundacion Instituto Valenciano de Oncologia (IVO)
        • Principal Investigator:
          • Ignacio Romero Noguera, MD
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Completed
        • University of South Alabama Mitchell Cancer Institute
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Completed
        • Alaska Women's Cancer Center
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • HonorHealth
        • Contact:
          • Theresa Thomas
        • Principal Investigator:
          • Lyndsay Willmott, MD
      • Tucson, Arizona, United States, 85711
        • Active, not recruiting
        • Arizona Oncology Associate, PC- HOPE
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Principal Investigator:
          • Heather Williams, MD
        • Contact:
          • Maroof Zafar
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center
        • Principal Investigator:
          • Mihae Song, MD
        • Contact:
          • Lorna Rodriguez, MD
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • Ramez Eskander, MD
        • Contact:
          • Linda Nguyen
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Contact:
          • Victoria Arman
        • Contact:
          • Garrett Crook
        • Principal Investigator:
          • Emily Pendergast, MD
      • Los Angeles, California, United States, 90033
        • Completed
        • USC/Norris Comprehensive Cancer Center
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Cancer Center
        • Contact:
          • Esmerelda Martinez
        • Principal Investigator:
          • Alberto Mendivil, MD
      • Orange, California, United States, 92868
        • Completed
        • UC Irvine Health
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Center
        • Contact:
          • Mohsin Rangwala
        • Principal Investigator:
          • Kirstin Bixel, MD
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis Comprehensive Cancer Center
        • Principal Investigator:
          • Hui Chen, MD
        • Contact:
          • Apinya Vorasaph
      • Santa Monica, California, United States, 90404
        • Recruiting
        • University of California Los Angeles (UCLA)
        • Contact:
          • Rosa Vazquez
        • Principal Investigator:
          • Alexandra Drakaki, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
          • Amelia Hardeman
        • Principal Investigator:
          • Lindsay Brubaker, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Completed
        • Yale Cancer Center
    • Florida
      • Fort Myers, Florida, United States, 33905
        • Completed
        • Florida Gynecologic Oncology/Regional Cancer Center
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center
        • Principal Investigator:
          • Brian Slomovitz, MD
        • Contact:
          • Evelyn Goya
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
          • Wilena Session
        • Principal Investigator:
          • Kristen Starbuck, MD
      • Gainesville, Georgia, United States, 30501
        • Completed
        • Northeast Georgia Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medicine
        • Principal Investigator:
          • John Moroney, MD
        • Contact:
          • Amber Kindt
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Medicine
        • Principal Investigator:
          • Daniela Matei, MD
        • Contact:
          • Peter Wojtowicz
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Cancer Center
        • Principal Investigator:
          • Rajul Kothari, MD
        • Contact:
          • Hilda Diaz
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
          • Kendrith Rowland
        • Principal Investigator:
          • Pratima Chalasani, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension St. Vicent Hospital, Inc.
        • Principal Investigator:
          • Michael Callahan, MD
        • Contact:
          • Cynthia Cruz
    • Iowa
      • Iowa City, Iowa, United States, 52252
        • Recruiting
        • University of Iowa
        • Principal Investigator:
          • David Bender, MD
        • Contact:
          • Heidi Haugland
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • LSU Health Sciences
        • Principal Investigator:
          • Amelia Jernigan, MD
        • Contact:
          • Alexander Yates
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Trials365, LLC
        • Principal Investigator:
          • Destin Black, MD
        • Contact:
          • Amanda Maranto
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Completed
        • American Oncology Partners of Maryland Pa
      • Bethesda, Maryland, United States, 20892
        • Active, not recruiting
        • National Institutes of Health, Clinical Center
      • Silver Spring, Maryland, United States, 20910
        • Completed
        • Holy Cross Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Dana Farber Cancer Institute
        • Principal Investigator:
          • Panagiotis Konstantinopoulos, MD, PhD
        • Contact:
          • Eleanor Estes
      • Worcester, Massachusetts, United States, 01605
        • Completed
        • University of Massachusetts Chan Medical School
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Contact:
          • Robert Morris, MD, PhD
        • Principal Investigator:
          • Ira Winer, MD, PhD
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • HCA Midwest
        • Contact:
          • Megan Werner
        • Principal Investigator:
          • Alaa Elbendary, DO
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center
        • Principal Investigator:
          • Donna McNamara, MD
        • Contact:
          • Lori Cappello, MSN, APN-C, CCRP
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of Nj
        • Contact:
          • Karen Jackson
        • Principal Investigator:
          • Aliza Leiser, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center
        • Principal Investigator:
          • Chrisann Kyi, MD
        • Contact:
          • Mauline Onsombi
      • New York, New York, United States, 10016
        • Recruiting
        • Laura & Isaac Perlmutter Cancer Center
        • Contact:
          • Karen Estok
        • Principal Investigator:
          • Bhavana Pothuri, MD
      • New York, New York, United States, 10128
        • Recruiting
        • Mount Sinai Health System
        • Contact:
          • Neha Kumarley
        • Principal Investigator:
          • Stephanie Blank, MD
      • New York, New York, United States, 10032
        • Completed
        • New York Presbyterian Hospital-Columbia University Medical Center
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Principal Investigator:
          • Rachael Turner, MD
        • Contact:
          • Kelly Mateer
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Completed
        • University of North Carolina at Chapel Hill
      • Pinehurst, North Carolina, United States, 28374
        • Active, not recruiting
        • FirstHealth of the Carolinas
    • Ohio
      • Canton, Ohio, United States, 44718
        • Completed
        • Gabrail Cancer Center
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Contact:
          • Rebecca Wirth
        • Principal Investigator:
          • Michael Guy, MD
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati Cancer Center
        • Principal Investigator:
          • Caroline Billingsley, MD
        • Contact:
          • Bonny Lami
      • Cleveland, Ohio, United States, 44195
        • Completed
        • Cleveland Clinic Foundation
      • Hilliard, Ohio, United States, 43026
        • Recruiting
        • Ohio State University
        • Principal Investigator:
          • David O'Malley, MD
        • Contact:
          • Kendall Lewis
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Stephenson Cancer Center at OU Health
        • Principal Investigator:
          • Debra Richardson, MD
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Completed
        • Oncology Associates of Oregon
      • Portland, Oregon, United States, 97239
        • Completed
        • Oregon Health & Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Active, not recruiting
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • West Penn Hospital
        • Principal Investigator:
          • Sarah Crafton, MD
        • Contact:
          • Siobhan Guyach
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Sanford Health
        • Principal Investigator:
          • Maria Bell, MD
        • Contact:
          • Ashley Johnson
    • Texas
      • Dallas, Texas, United States, 75390
        • Completed
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75231
        • Completed
        • Texas Oncology-Dallas Presbyterian Hospital
      • Fort Worth, Texas, United States, 76104
        • Completed
        • Texas Oncology
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas, MD Anderson Cancer Center
        • Principal Investigator:
          • Funda Meric-Bernstam, MD
        • Contact:
          • Anjali Raina
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute, University of Utah
        • Principal Investigator:
          • Theresa Werner, MD
        • Contact:
          • Celine Saenz
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Health System
        • Principal Investigator:
          • Linda Duska, MD
        • Contact:
          • Alfredo Villalobos-Perez
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
          • Melanie Hamilton
        • Principal Investigator:
          • Chelsea Salyer, MD
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Center
        • Principal Investigator:
          • Fernanda Musa, MD
        • Contact:
          • Thao Amy Nguyen
      • Seattle, Washington, United States, 98109
        • Completed
        • Fred Hutchinson Cancer Center
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center and Children's Hospital
        • Contact:
          • Jodie Mactagone
        • Principal Investigator:
          • Melanie Bergman, MD
      • Spokane, Washington, United States, 99208
        • Completed
        • Summit Cancer Center
      • Vancouver, Washington, United States, 98684
        • Completed
        • Northwest Cancer Specialists, P.C.
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert And Medical College Of Wisconsin
        • Contact:
          • Subarna Paul
        • Principal Investigator:
          • William Bradley, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: General

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

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

    Arms 1 and 2

    1. All high-grade epithelial endometrial histological subtypes are eligible including: endometrioid (all Grade 3), serous, carcinosarcomas, clear-cell carcinoma, and mixed histologies.

      Note: Subjects with p53 mutant Grade 2 endometrioid cancer are eligible

      Arms 3 and 4

    2. Serous carcinoma or mixed tumors with a majority component of serous carcinoma or carcinosarcoma where the carcinomatous component is serous carcinoma.

  3. Treatment History Requirements:

    Arms 1 and 2

    1. Subject must have received prior platinum-based chemotherapy
    2. Subject must have received prior anti-PD-(L)1 therapy
    3. Subject must not have received more than three lines of prior systemic therapy Arms 3 and 4
    1. Subject must have received prior platinum-based chemotherapy
    2. Subject must have received prior anti-PD-(L)1 therapy
    3. Subject must not have received more than two lines of prior systemic therapy
  4. Participant must have histologically confirmed metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen.
  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.

  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.

    Newly obtained is defined as a specimen taken after written informed consent is obtained, during the 28-day Screening period.

    Note: Subjects at EU sites are not eligible for Arm 1 and Arm 2

  7. For all subjects participating in Arm 3 and 4, archival tumor tissue must be provided either during or after screening either as a tissue block or at least 20 unstained slides.

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

    1. Alopecia is accepted.
    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).
    3. Neuropathy events from prior cytotoxic therapies stabilized at ≤ Grade 2 are accepted.
  9. Participant must have an Eastern Cooperative Oncology Group Performance Status 0 or 1.
  10. Participant must have an estimated life expectancy of longer than 3 months in the clinical judgment of the investigator.

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

    1. Absolute neutrophil count > 1500 cells/µL without growth factor support within 1 week prior to obtaining the hematology values at Screening.
    2. Hemoglobin ≥ 9.0 g/dL.
    3. Platelets ≥ 150,000 cells/µL without transfusion within 1 week prior to obtaining the hematology values at Screening.
    4. Renal function is defined as Glomerular filtration rate (GFR) ≥ 50 mL/min/1.73m2. Note: GFR may be estimated using site standard methods (e.g., CKD-EPI, MDRD, or Cockcroft-Gault) or measured using 24-hour urine collection or Chrome-EDTA clearance, as per site standard practice.
    5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); ≤ 5 × ULN if liver metastases are present.
    6. Total bilirubin ≤ 1.5 × ULN not associated with Gilbert's syndrome. If associated with Gilbert's syndrome ≤ 3 x ULN is acceptable.
    7. Serum albumin ≥ 3 g/dL.

  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:

    1. Prothrombin time within 1.5 x ULN.
    2. Activated partial thromboplastin time within 1.5 x ULN.

Exclusion Criteria: General

  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. Participant has mesenchymal tumors of the uterus.
  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. Participant had systemic therapy or radiation therapy within 3 weeks prior to the first dose of study drug.
  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. Participant has a history of clinically meaningful coagulopathy, bleeding diathesis.

  7. Participant has cardiovascular disease, defined as:

    1. Uncontrolled hypertension defined as blood pressure > 160/90 mmHg at Screening confirmed by repeat (medication permitted).
    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).
    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).
  8. Participant has a history of major surgery within 4 weeks of Screening.
  9. Participant has experienced bowel obstruction related to the current cancer within the last 4 weeks 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.
  10. Participant has taken a prior cell cycle CHK1 inhibitor, including ACR-368

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: ACR-368
ACR-368 is an experimental drug
Other Names:
  • prexasertib
Diagnostic test: OncoSignature
Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy
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.
Drug: ACR-368
ACR-368 is an experimental drug
Other Names:
  • prexasertib
Diagnostic test: OncoSignature
Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy
Drug: Gemcitabine
Sensitization of tumor cells is provided through administration of ULDG
Experimental: OncoSignature Unselected (Serous All-Comers) ACR-368 with ULDG
Arm 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.
Drug: ACR-368
ACR-368 is an experimental drug
Other Names:
  • prexasertib
Drug: Gemcitabine
Sensitization of tumor cells is provided through administration of ULDG
Experimental: OncoSignature Unselected (Serous All-Comers) ACR-368
Arm 4: Participants who are OncoSignature Unselected will receive ACR-368. The Phase 2 Study will assess the efficacy and safety of ACR-368.
Drug: ACR-368
ACR-368 is an experimental drug
Other Names:
  • prexasertib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assess Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.
Response will be assessed every 8 weeks from baseline through 2 years or death.
Arm 2: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects that are OncoSignature Negative.
Time Frame: Response will be assessed every 8 weeks from baseline through 2 years or death.
Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.
Response will be assessed every 8 weeks from baseline through 2 years or death.
Arm 3: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers).
Time Frame: Response will be assessed every 8 weeks from baseline through 2 years or death.
Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.
Response will be assessed every 8 weeks from baseline through 2 years or death.
Arm 4: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers).
Time Frame: Response will be assessed every 8 weeks from baseline through 2 years or death.
Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic
Response will be assessed every 8 weeks from baseline through 2 years or death.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
Time Frame: Up to 2 years
The time from initial response until investigator assessed progressive disease for all subjects who achieve a confirmed objective response.
Up to 2 years
Arm 2 and Arm 3: Adverse Events (AEs) for ACR-368 with ULDG sensitization
Time Frame: AEs will be assessed from baseline through 2 years or death.
Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.
AEs will be assessed from baseline through 2 years or death.
All Arms: Limited pharmacokinetic (PK) testing.
Time Frame: Dose of ACR-368 at day 1 and day 15 of first cycle.
Cmax and Tmax will be assessed in the first cycle. Blood samples will be collected at baseline, end of infusion, hour 2 and hour 4.
Dose of ACR-368 at day 1 and day 15 of first cycle.
Overall Survival (OS)
Time Frame: Up to 2 years
The time from date of enrollment until date of death.
Up to 2 years
Progression-free Survival (PFS)
Time Frame: Up to 2 years
The time from date of enrollment until disease progression or death whichever occurs first.
Up to 2 years
Arm 1 and Arm 4: Adverse Events (AEs) for ACR-368
Time Frame: AEs will be assessed from baseline through 2 years or death.
Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.
AEs will be assessed from baseline through 2 years or death.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acrivon Therapeutics

Collaborators

GOG Foundation

Investigators

  • Principal Investigator: Panagiotis Konstantinopoulos, MD, Dana-Farber Cancer Institute (DFCI)
  • Principal Investigator: Isabelle Ray-Coquard, MD, Centre Léon Bérard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

August 29, 2022

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

September 16, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACR-368-201 (GOG 3082)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometrial Adenocarcinoma

Clinical Trials on ACR-368

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe