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New treatment option for Endometrial Adenocarcinoma
Official title A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma
ClinicalTrials.gov ID: NCT05548296
What this study is testing
What is ACR-368?
ACR-368 is an investigational medicine, being studied as a potential treatment for endometrial adenocarcinoma.
Also referred to as prexasertib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- General
- 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...
- Serous carcinoma or mixed tumors with a majority component of serous carcinoma or carcinosarcoma where the carcinomatous component is serous...
You likely can't join if
- General
- Participant with known symptomatic brain metastases requiring \> 10 mg/day of prednisolone (or its equivalent). Participants with previously...
- 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...
- 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...
See the full eligibility criteria
Who can join
- General
- 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: people with p53 mutant Grade 2...
- 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...
- 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...
- For all people 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...
- 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.
What rules you out
- General
- 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...
- 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. people with planned therapeutic paracentesis or...
- 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.
- 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...
- 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...
- 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...
- Participant has taken a prior cell cycle CHK1 inhibitor, including ACR-368
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Anchorage, Alaska, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Duarte, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Fort Myers, Florida, United States
- Miami Beach, Florida, United States
- Atlanta, Georgia, United States
- Gainesville, Georgia, United States
- Chicago, Illinois, United States
+ 56 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Anchorage, Alaska, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Duarte, California, United States and 70 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.