PREXASERTIB LACTATE MONOHYDRATE for Endometrial cancer|Endometrial adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Subjects who are 18 years of age or older at time of consent."}
• {"criterion_text":"- Subject must have at least 1 measurable lesion per RECIST v1.1 criteria (by local Investigator). Subject must have radiographic evidence of disease progression based on RECIST v1.1 criteria following the most recent line of treatment."}
• {"criterion_text":"- Subject must be willing to provide archival tumor, either as a tissue block or at least 20 unstained slides, if available."}
• {"criterion_text":"- Subject must have stabilized or recovered (Grade 1 or baseline) from all prior therapy -related toxicities (except alopecia, endocrine events from prior immunotherapy and neuropathy events from prior cytotoxic therapies stabilized at ≤ Grade 2)."}
• {"criterion_text":"- Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1."}
• {"criterion_text":"- Subject received treatment with moderate or strong inhibitors of CYP1A2 within 14 days prior to the first dose of study drug. Note: Individual cases may be discussed with the Sponsor or Medical Monitor."}
• {"criterion_text":"- Subject must have an estimated life expectancy of longer than 3 months in the clinical judgement of the Investigator."}
• {"criterion_text":"- Subject must have adequate organ function at Screening, as defined in the protocol."}
• {"criterion_text":"- Subject must have adequate coagulation profile as defined in the protocol."}
• {"criterion_text":"- Subject is willing and able to comply with clinical trial instructions and requirements."}
• {"criterion_text":"- Subject must be able to give signed, written informed consent."}
• {"criterion_text":"- Subject must have histologically documented, high-grade endometrial cancer."}
• {"criterion_text":"- Treatment history: 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 any type of prior systemic therapy."}
• {"criterion_text":"- Subject must have histologically confirmed metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen. Confirmation of progression must be established using a set of imaging that will also be used to determine the presence of at least one measurable lesion."}

Exclusion criteria

• {"criterion_text":"- Subject with known symptomatic brain metastases requiring > 10 mg/day of prednisolone (or its equivalent). Subjects 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."}
• {"criterion_text":"- Subject has taken a prior cell cycle CHK1 inhibitor, including ACR-368."}
• {"criterion_text":"- Subject has mesenchymal tumors of the uterus."}
• {"criterion_text":"- Subject has a history of clinically meaningful ascites, defined as a 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."}
• {"criterion_text":"- Subject had systemic therapy or radiation therapy within 3 weeks prior to the first dose of study drug."}
• {"criterion_text":"- Subjects has known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is considered uncontrolled based on the criteria included in protocol."}
• {"criterion_text":"- Subject has a history of clinically meaningful coagulopathy, bleeding diathesis."}
• {"criterion_text":"- Subject has cardiovascular disease, as defined in the protocol."}
• {"criterion_text":"- Subject has a history of major surgery within 4 weeks of Screening."}
• {"criterion_text":"- Subject has bowel obstruction related to the current cancer within the last 6 months 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."}

Primary endpoints

• {"endpoint_text":"- Confirmed ORR in subjects per RECIST v1.1 by CT scan and/or MRI.","definition_or_measurement_approach":"Objective Response Rate confirmed according to RECIST v1.1 assessed by CT scan and/or MRI (translations reference blinded independent central review/BICR)."}

Secondary endpoints

• {"endpoint_text":"- Incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment. Changes in clinical laboratory parameters, vital signs, ECG parameters, and physical examination findings.","definition_or_measurement_approach":"Adverse events graded per NCI CTCAE v5.0; clinical labs, vitals, ECGs and physical exam changes monitored and recorded per protocol."}
• {"endpoint_text":"- DOR calculated from the time of first objective response detection according to RECIST v1.1 by CT scan and/or MRI and the time of assessed progressive disease . PFS and OS based on analysis of Kaplan-Meier estimates by CT scans and/or MRI . CBR, i.e., DCR maintained for at least 4 months, by CT scans and/or MRI. Progression-free rate at 6 months and OS at 6, 9, and 12 months, by CT scans and/or MRI.","definition_or_measurement_approach":"Duration of Response (DOR) from first documented objective response to progression per RECIST v1.1 by CT/MRI; PFS and OS estimated by Kaplan-Meier using imaging (CT/MRI); Clinical Benefit Rate defined as disease control rate maintained ≥4 months; timepoint rates at 6, 9, 12 months by imaging."}
• {"endpoint_text":"- Confirmed ORR in subjects per RECIST v1.1 by CT scans and/or MRI. DOR calculated from the time of first objective response detection according to RECIST v1.1 by CT scan and/or MRI and the time of assessed progressive disease . CBR, i.e., DCR maintained for at least 4 months, by CT scans and/or MRI. PFS based on analysis of Kaplan-Meier estimates.","definition_or_measurement_approach":"Same imaging-based efficacy endpoints (RECIST v1.1) with analyses including ORR, DOR, CBR (DCR ≥4 months), and PFS via Kaplan-Meier."}
• {"endpoint_text":"- Change from Baseline in NRS and FACIT questionnaire scores.","definition_or_measurement_approach":"Patient-reported outcomes: change from baseline in Numeric Rating Scale (NRS) and FACIT questionnaire scores per schedule."}

France

Earliest CTIS Part Ii Submission Date

12-03-2026

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

13

Number Of Sites

4

Number Of Participants

12

Germany

Earliest CTIS Part Ii Submission Date

24-02-2026

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

27

Number Of Sites

3

Number Of Participants

12

Italy

Earliest CTIS Part Ii Submission Date

27-02-2026

Latest Decision Or Authorization Date

24-03-2026

Processing Time Days

25

Number Of Sites

7

Number Of Participants

24

Spain

Earliest CTIS Part Ii Submission Date

18-03-2026

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

9

Number Of Sites

7

Number Of Participants

24

Primary sponsor

Full Name

Acrivon Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Worldwide Clinical Trials d.o.o.

Responsibilities

various sponsor duties (codes listed in CTIS)

Name

Scout Clinical

Responsibilities

patient reimbursement and travel arrangements

Name

Acm Global Central Laboratory Limited

Responsibilities

lab kits distribution

Name

Bioclinica Inc.

Responsibilities

CCI

Third parties

• {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"Lab kits distribution","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement and travel arrangements","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Croatia","full_name":"Worldwide Clinical Trials d.o.o.","duties_or_roles":"sponsorDuties codes: 1,12,13,2,3,5,6,7,8,9","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"CCI","organisation_type":"Laboratory/Research/Testing facility"}