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Endometrial AdenocarcinomaPhase 2NCT05548296

A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma

A Phase 2 study testing ACR-368, Gemcitabine and OncoSignature in people with Endometrial Adenocarcinoma, run by Acrivon Therapeutics at 90 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Adenocarcinoma
What is being tested?
ACR-368, Gemcitabine and OncoSignature
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
90 sitesin 5 countries
Study dates
29 Aug 2022to 30 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be able to give signed, written informed consent.
  • Participant must have histologically documented, high-grade endometrial cancer.
  • Arms 1 and 2
  • 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
Show all 39Show fewer
  • Serous carcinoma or mixed tumors with a majority component of serous carcinoma or carcinosarcoma where the carcinomatous component is serous carcinoma.
  • Treatment History Requirements:
  • Arms 1 and 2
  • Subject must have received prior platinum-based chemotherapy
  • Subject must have received prior anti-PD-(L)1 therapy
  • Subject must not have received more than three lines of prior systemic therapy Arms 3 and 4
  • <!-- -->
  • Subject must have received prior platinum-based chemotherapy
  • Subject must have received prior anti-PD-(L)1 therapy
  • Subject must not have received more than two lines of prior systemic 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.
  • Note: Subjects at EU sites are not eligible for Arm 1 and Arm 2
  • 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.
  • 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 in the clinical judgment of the investigator.
  • Participant must have adequate organ function at Screening, defined as:
  • Absolute neutrophil count > 1500 cells/µL without growth factor support within 2 weeks 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.
  • 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.
  • 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.

Who cannot join

  • 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.
  • Participant has mesenchymal tumors of the uterus.
  • 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.
  • Participant had systemic therapy or radiation therapy within 3 weeks prior to the first dose of study drug.
  • 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.
  • Participant has a history of clinically meaningful coagulopathy, bleeding diathesis.
Show all 13Show fewer
  • Participant has cardiovascular disease, defined as:
  • Uncontrolled hypertension defined as blood pressure > 160/90 mmHg at Screening confirmed by repeat (medication permitted).
  • 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).
  • 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).
  • Participant has a history of major surgery within 4 weeks of Screening.
  • 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.
  • Participant has taken a prior cell cycle CHK1 inhibitor, including ACR-368

Trial locations and contacts

90 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Mansoor Raza Mirza, MD contact

617-207-8976

ACR-368-201ClinicalTrial@acrivon.com

Jeanie Tang contact

ACR-368-201ClinicalTrial@acrivon.com

90 sites in 5 countries

United States69 sites, 42 recruiting

  • Alaska Women's Cancer Center

    Anchorage, Alaska, 99508

    Completed

  • Emory University

    Atlanta, Georgia, 30322

    Wilena Session

    Kristen Starbuck, MD

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Amelia Hardeman

    Lindsay Brubaker, MD

    Recruiting

  • American Oncology Partners of Maryland PA

    Bethesda, Maryland, 20817

    Completed

  • National Institutes of Health, Clinical Center

    Bethesda, Maryland, 20892

    Active, not recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

    Eleanor Estes

    Panagiotis Konstantinopoulos, MD, PhD

    Recruiting

  • Gabrail Cancer Center

    Canton, Ohio, 44718

    Completed

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Rebecca Wirth

    Michael Guy, MD

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Completed

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

    Alfredo Villalobos-Perez

    Linda Duska, MD

    Recruiting

  • Northwestern Medicine

    Chicago, Illinois, 60611

    Peter Wojtowicz

    Daniela Matei, MD

    Recruiting

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

    Hilda Diaz

    Rajul Kothari, MD

    Recruiting

  • University of Chicago Medicine

    Chicago, Illinois, 60637

    Amber Kindt

    John Moroney, MD

    Recruiting

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45267

    Bonny Lami

    Caroline Billingsley, MD

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Completed

  • Texas Oncology-Dallas Presbyterian Hospital

    Dallas, Texas, 75231

    Completed

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Completed

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Robert Morris, MD, PhD

    Ira Winer, MD, PhD

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010

    Lorna Rodriguez, MD

    Mihae Song, MD

    Recruiting

  • Oncology Associates of Oregon

    Eugene, Oregon, 97401

    Completed

  • Florida Gynecologic Oncology/Regional Cancer Center

    Fort Myers, Florida, 33905

    Completed

  • Texas Oncology

    Fort Worth, Texas, 76104

    Completed

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

    Completed

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Lori Cappello, MSN, APN-C, CCRP

    Donna McNamara, MD

    Recruiting

  • Ohio State University

    Hilliard, Ohio, 43026

    Kendall Lewis

    David O'Malley, MD

    Recruiting

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

    Anjali Raina

    Funda Meric-Bernstam, MD

    Recruiting

  • Ascension St. Vicent Hospital, Inc.

    Indianapolis, Indiana, 46260

    Cynthia Cruz

    Michael Callahan, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52252

    Heidi Haugland

    David Bender, MD

    Recruiting

  • HCA Midwest

    Kansas City, Missouri, 64132

    Megan Werner

    Alaa Elbendary, DO

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037

    Linda Nguyen

    Ramez Eskander, MD

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Maroof Zafar

    Heather Williams, MD

    Recruiting

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Completed

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Victoria Arman

    Garrett Crook

    Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

    Evelyn Goya

    Brian Slomovitz, MD

    Recruiting

  • Froedtert and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Subarna Paul

    William Bradley, MD

    Recruiting

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

    Completed

  • Rutgers Cancer Institute of NJ

    New Brunswick, New Jersey, 08903

    Karen Jackson

    Aliza Leiser, MD

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06520

    Completed

  • LSU Health Sciences

    New Orleans, Louisiana, 70112

    Alexander Yates

    Amelia Jernigan, MD

    Recruiting

  • Laura & Isaac Perlmutter Cancer Center

    New York, New York, 10016

    Karen Estok

    Bhavana Pothuri, MD

    Recruiting

  • New York Presbyterian Hospital-Columbia University Medical Center

    New York, New York, 10032

    Completed

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

    Mauline Onsombi

    Chrisann Kyi, MD

    Recruiting

  • Mount Sinai Health System

    New York, New York, 10128

    Neha Kumarley

    Stephanie Blank, MD

    Recruiting

  • Hoag Cancer Center

    Newport Beach, California, 92663

    Esmerelda Martinez

    Alberto Mendivil, MD

    Recruiting

  • Stephenson Cancer Center at OU Health

    Oklahoma City, Oklahoma, 73104

    Ashley Willy, phase1-referrals@ouhsc.edu

    Debra Richardson, MD

    Recruiting

  • UC Irvine Health

    Orange, California, 92868

    Completed

  • Stanford Cancer Center

    Palo Alto, California, 94304

    Mohsin Rangwala

    Kirstin Bixel, MD

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Active, not recruiting

  • HonorHealth

    Phoenix, Arizona, 85016

    Theresa Thomas

    Lyndsay Willmott, MD

    Recruiting

  • FirstHealth of the Carolinas

    Pinehurst, North Carolina, 28374

    Active, not recruiting

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Siobhan Guyach

    Sarah Crafton, MD

    Recruiting

  • Oregon Health & Sciences University

    Portland, Oregon, 97239

    Completed

  • Women & Infants Hospital

    Providence, Rhode Island, 02905

    oncologyresearch@wihri.org

    Cara Mathews, MD

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Active, not recruiting

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Kelly Mateer

    Rachael Turner, MD

    Recruiting

  • University of California, Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Apinya Vorasaph

    Hui Chen, MD

    Recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

    Celine Saenz

    Theresa Werner, MD

    Recruiting

  • University of California Los Angeles (UCLA)

    Santa Monica, California, 90404

    Rosa Vazquez

    Alexandra Drakaki, MD

    Recruiting

  • Swedish Cancer Center

    Seattle, Washington, 98104

    Thao Amy Nguyen

    Fernanda Musa, MD

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Completed

  • Trials365, LLC

    Shreveport, Louisiana, 71103

    Amanda Maranto

    Destin Black, MD

    Recruiting

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

    Completed

  • Sanford Health

    Sioux Falls, South Dakota, 57104

    Ashley Johnson

    Maria Bell, MD

    Recruiting

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington, 99204

    Jodie Mactagone

    Melanie Bergman, MD

    Recruiting

  • Summit Cancer Center

    Spokane, Washington, 99208

    Completed

  • Arizona Oncology Associate, PC- HOPE

    Tucson, Arizona, 85711

    Active, not recruiting

  • Carle Cancer Center

    Urbana, Illinois, 61801

    Kendrith Rowland

    Pratima Chalasani, MD

    Recruiting

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684

    Completed

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01605

    Completed

Other trials in United States

Italy7 sites, 7 recruiting

  • CRO Aviano

    Aviano

    Michele Bartoletti, MD

    Recruiting

  • Istituto Clinico Cannizzaro Catania

    Catania

    Giuseppa Scandurra, MD

    Recruiting

  • Istituto Europeo di Oncologia

    Milan

    Nicoletta Colombo, MD

    Recruiting

  • Fondazione Pascale Istituto Tumori

    Naples

    Carmela Pisano, MD

    Recruiting

  • Humanitas University

    Pieve Emanuele

    Domenica Lorusso, MD

    Recruiting

  • Policlinico Gemelli

    Roma

    Anna Fagotti, MD

    Recruiting

  • Ospedale Mauriziano Torino

    Turin

    Giorgio Valabrega, MD

    Recruiting

Other trials in Italy

Spain7 sites, 7 recruiting

  • Hospital Clínic de Barcelona

    Barcelona

    Lydia Gaba Garcia, MD

    Recruiting

  • Hospital Universitario Puerta de Hierro

    Barcelona

    Ana Oaknin Benzaquen, MD

    Not yet recruiting

  • Vall d'Hebron Institute of Oncology (VHIO)

    Barcelona

    Lorena Farinas, MD

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid

    Luis Manuel Manso Sanchez, MD

    Recruiting

  • Hospital Universitario La Paz

    Madrid

    Andrés Redondo Sanchez, MD

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid

    Eva María Guerra Alia, MD

    Recruiting

  • Fundacion Instituto Valenciano de Oncologia (IVO)

    Valencia

    Ignacio Romero Noguera, MD

    Recruiting

Other trials in Spain

France4 sites, 4 recruiting

  • Centre François Baclesse

    Caen

    Florence Joly-Lobbedez, MD

    Recruiting

  • Centre Léon Bérard

    Lyon

    Isabelle Ray-Coquard, MD

    Recruiting

  • Insitute de Cancérologie de l'Ouest

    Saint-Herblain

    Jean-Sebastien Frenel, MD

    Recruiting

  • Institute Gustave Roussy

    Villejuif

    Alexandra Leary, MD

    Recruiting

Other trials in France

Germany3 sites, 3 recruiting

  • KEM | Evang. Kliniken Essen-Mitte

    Essen

    Philipp Harter, MD

    Not yet recruiting

  • Universitätsklinikum Münster, Klinik für Frauenheilkunde und Geburtshilfe

    Münster

    Lars Hanker, MD

    Not yet recruiting

  • Universitätsklinikum Ulm, Frauenheilunde und Geburtshilfe

    Ulm

    Sabine Heublein, MD

    Not yet recruiting

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
ACR-368, Gemcitabine, OncoSignature
Keywords
Endometrial Cancer, Endometrial Neoplasm, Ultralow dose gemcitabine, ACR-368
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACR-368Drug

    Also called prexasertib

    ACR-368 is an experimental drug

  • GemcitabineDrug

    Sensitization of tumor cells is provided through administration of ULDG

  • OncoSignatureDiagnostic test

    Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy

Study groups in NCT05548296
Study groupRoleWhat they receive
OncoSignature Positive TumorsExperimentalARM 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.
Receives: Drug: ACR-368; Diagnostic Test: OncoSignature
OncoSignature Negative TumorsExperimentalArm 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.
Receives: Drug: ACR-368; Drug: Gemcitabine; Diagnostic Test: OncoSignature
OncoSignature Unselected (Serous All-Comers) ACR-368 with ULDGExperimentalArm 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.
Receives: Drug: ACR-368; Drug: Gemcitabine
OncoSignature Unselected (Serous All-Comers) ACR-368ExperimentalArm 4: Participants who are OncoSignature Unselected will receive ACR-368. The Phase 2 Study will assess the efficacy and safety of ACR-368.
Receives: Drug: ACR-368

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arm 1: Anti-tumor activity of ACR-368 in Endometrial cancer subjects that are OncoSignature Positive.

    Assess Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.

    Measured: Response will be assessed every 8 weeks from baseline through 2 years or death.

  2. Arm 2: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects that are OncoSignature Negative.

    Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.

    Measured: Response will be assessed every 8 weeks from baseline through 2 years or death.

  3. Arm 3: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers).

    Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.

    Measured: Response will be assessed every 8 weeks from baseline through 2 years or death.

  4. Arm 4: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers).

    Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic

    Measured: Response will be assessed every 8 weeks from baseline through 2 years or death.

Secondary outcomes (6)

  1. Arm 1 and Arm 4: Adverse Events (AEs) for ACR-368

    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.

    Measured: AEs will be assessed from baseline through 2 years or death.

  2. Arm 2 and Arm 3: Adverse Events (AEs) for ACR-368 with ULDG sensitization

    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.

    Measured: AEs will be assessed from baseline through 2 years or death.

  3. All Arms: Limited pharmacokinetic (PK) testing.

    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.

    Measured: Dose of ACR-368 at day 1 and day 15 of first cycle.

  4. Overall Survival (OS)

    The time from date of enrollment until date of death.

    Measured: Up to 2 years

  5. Duration of Response (DOR)

    The time from initial response until investigator assessed progressive disease for all subjects who achieve a confirmed objective response.

    Measured: Up to 2 years

  6. Progression-free Survival (PFS)

    The time from date of enrollment until disease progression or death whichever occurs first.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2022
  2. Study start29 Aug 2022
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants with an OncoSignature Positive test will enter the Arm 1 cohort that will assess the efficacy of ACR-368 as monotherapy in endometrial cancer. Participants with an OncoSignature Negative test will enter the Arm 2 cohort to assess the efficacy and safety of ACR-368 with ULDG sensitization. Arm 2 is completed and not enrolling. Participants without OncoSignature testing will enter an OncoSignature Unselected Arm 3 cohort to assess the efficacy and safety of ACR-368 with ULDG sensitization or in the Arm 4 cohort to assess the efficacy and safety of ACR-368 monotherapy.
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05548296
Sponsor's protocol ID
ACR-368-201 (GOG 3082)
Status last verified
Jun 2026
First submitted
29 Aug 2022
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ACR-368, Gemcitabine and OncoSignature in people with Endometrial Adenocarcinoma, run by Acrivon Therapeutics at 90 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Italy, Spain, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mansoor Raza Mirza, MD (617-207-8976, ACR-368-201ClinicalTrial@acrivon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05548296.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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