OncoMatch/Clinical Trials/NCT05548296
A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma
Is NCT05548296 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including ACR-368 and Gemcitabine for endometrial adenocarcinoma.
Treatment: ACR-368 · Gemcitabine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Endometrial Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: platinum-based chemotherapy
Subject must have received prior platinum-based chemotherapy
Must have received: anti-PD-1/PD-L1 therapy
Subject must have received prior anti-PD-(L)1 therapy
Cannot have received: cell cycle CHK1 inhibitor (ACR-368)
Participant has taken a prior cell cycle CHK1 inhibitor, including ACR-368
Lab requirements
Blood counts
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
Kidney function
Glomerular filtration rate (GFR) ≥ 50 mL/min/1.73m2
Liver function
AST and ALT ≤ 3 × ULN; ≤ 5 × ULN if liver metastases are present; total bilirubin ≤ 1.5 × ULN not associated with Gilbert's syndrome; ≤ 3 × ULN if associated with Gilbert's syndrome; serum albumin ≥ 3 g/dL
Cardiac function
Uncontrolled hypertension > 160/90 mmHg at Screening; history of torsades de pointes, significant ECG abnormalities, unstable cardiac arrhythmia, pathologic symptomatic bradycardia, left bundle branch block, second degree AV block type II, third degree AV block, Grade ≥ 2 bradycardia, uncorrected hypokalemia, congenital long QT syndrome, prolonged QT interval due to medications, QTcF > 450 msec (men) or > 470 msec (women); symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction < 20%, TIA, or CVA within 6 months of Day 1)
Participant must have adequate organ function at Screening, defined as: ... Participant has cardiovascular disease, defined as: ...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana Farber Cancer Institute · Boston, Massachusetts
- University of Massachusetts Chan Medical School · Worcester, Massachusetts
- Karmanos Cancer Institute · Detroit, Michigan
- HCA Midwest · Kansas City, Missouri
- John Theurer Cancer Center at Hackensack University Medical Center · Hackensack, New Jersey
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05548296 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cell cycle CHK1 inhibitor disqualifies patients from enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages