> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-2-study-of-acr-368-in-endometrial-adenocarcinoma-6a063030-8542-480d-b9a2-e9309f8192d8 > Record changed: 2026-10-13 # A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma NCT05548296 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) Participants 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) Lead sponsor Acrivon Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) Start date 2022-08-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) Number of sites 90 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Short title** A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Official title** A Phase 2 Study of ACR-368 Therapy in Subjects With Endometrial Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) ## Dates **Completion date** 2027-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **First posted** 2022-09-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Registry last updated** 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Primary completion date** 2027-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Start date** 2022-08-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) ## Size and sites **Participants** 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Planned participants** 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Number of sites** 90 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Lead sponsor** Acrivon Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) ## Identifiers **Registry ID** NCT05548296 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **ClinicalTrials.gov ID** NCT05548296 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) ## Outcomes ### Primary outcomes 1. Arm 1: Anti-tumor activity of ACR-368 in Endometrial cancer subjects that are OncoSignature Positive. Timeframe: 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. 2. Arm 2: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects that are OncoSignature Negative. Timeframe: 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. 3. Arm 3: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers). Timeframe: 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. 4. Arm 4: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers). Timeframe: 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 ### Secondary outcomes 1. Arm 1 and Arm 4: Adverse Events (AEs) for ACR-368 Timeframe: 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. 2. Arm 2 and Arm 3: Adverse Events (AEs) for ACR-368 with ULDG sensitization Timeframe: 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. 3. All Arms: Limited pharmacokinetic (PK) testing. Timeframe: 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. 4. Overall Survival (OS) Timeframe: Up to 2 years The time from date of enrollment until date of death. 5. Duration of Response (DOR) Timeframe: Up to 2 years The time from initial response until investigator assessed progressive disease for all subjects who achieve a confirmed objective response. 6. Progression-free Survival (PFS) Timeframe: Up to 2 years The time from date of enrollment until disease progression or death whichever occurs first. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 2 weeks 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) ## Sites - University of South Alabama Mitchell Cancer InstituteMobile, United StatesCompleted - Alaska Women's Cancer CenterAnchorage, United StatesCompleted - HonorHealthPhoenix, United StatesRecruiting - Arizona Oncology Associate, PC- HOPETucson, United StatesActive, not recruiting - University of Arkansas for Medical SciencesLittle Rock, United StatesRecruiting - City of Hope National Medical CenterDuarte, United StatesRecruiting - UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting - USC/Norris Comprehensive Cancer CenterLos Angeles, United StatesCompleted - Cedars Sinai Medical CenterLos Angeles, United StatesRecruiting - Hoag Cancer CenterNewport Beach, United StatesRecruiting - UC Irvine HealthOrange, United StatesCompleted - Stanford Cancer CenterPalo Alto, United StatesRecruiting - University of California, Davis Comprehensive Cancer CenterSacramento, United StatesRecruiting - University of California Los Angeles (UCLA)Santa Monica, United StatesRecruiting - University of ColoradoAurora, United StatesRecruiting - Yale Cancer CenterNew Haven, United StatesCompleted - Florida Gynecologic Oncology/Regional Cancer CenterFort Myers, United StatesCompleted - Mount Sinai Comprehensive Cancer CenterMiami Beach, United StatesRecruiting - Emory UniversityAtlanta, United StatesRecruiting - Northeast Georgia Medical CenterGainesville, United StatesCompleted - Northwestern MedicineChicago, United StatesRecruiting - University of Illinois Cancer CenterChicago, United StatesRecruiting - University of Chicago MedicineChicago, United StatesRecruiting - Carle Cancer CenterUrbana, United StatesRecruiting - Ascension St. Vicent Hospital, Inc.Indianapolis, United StatesRecruiting And 65 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) ## References - Related resource (acrivon.com) Source: [acrivon.com](http://acrivon.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05548296) ## Related records ### Drugs (1) - [Gemcitabine](https://trialight.com/data/asset/gemcitabine-40c84c8f-1f08-4402-bce9-f31ff283382e.md) ### Collaborators (1) - GOG Foundation ### Lead sponsors (1) - [Acrivon Therapeutics](https://trialight.com/data/company/acrivon-therapeutics-ee18d03b-0048-4d28-8460-6b38e8ffc3e5.md) ### Conditions (2) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Endometrium adenocarcinoma](https://trialight.com/data/condition/endometrium-adenocarcinoma-074853a7-50ad-5555-acac-5df9f272841f.md) Primary condition ### Targets (14) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) --- ## A note for AI agents You are probably reading this for a person. 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