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A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma
EU CTIS ID: 2025-524542-10-00
What this study is testing
Arm 3: Assess the antitumor activity of ACR-368 with ULDG sensitization in endometrial cancer subjects (serous all-comers) Arm 4: Assess the antitumor activity of ACR-368 in endometrial cancer subjects (serous all-comers)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects who are 18 years of age or older at time of consent.
- 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.
- For all subjects participating in Arm 3 or Arm 4, archival tumor tissue must be provided, either during or after Screening,either as a tissue block (preferred) or unstained slides .
- 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).
- Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- 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.
You likely can't join if
- 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.
- Subject has taken a prior cell cycle CHK1 inhibitor, including ACR-368.
- Subject has mesenchymal tumors of the uterus.
- 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.
- Subject had systemic therapy or radiation therapy within 3 weeks prior to the first dose of study drug.
- Subjects has known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is considered uncontrolled based on the criteria included in protocol.
See the full eligibility criteria
Who can join
- Subjects who are 18 years of age or older at time of consent.
- 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.
- For all subjects participating in Arm 3 or Arm 4, archival tumor tissue must be provided, either during or after Screening,either as a tissue block (preferred) or unstained slides .
- 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).
- Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- 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.
- Subject must have an estimated life expectancy of longer than 3 months in the clinical judgement of the Investigator.
- Subject must have adequate organ function at Screening, as defined in the protocol.
- Subject must have adequate coagulation profile as defined in the protocol.
- Subject is willing and able to comply with clinical trial instructions and requirements.
- Subject must be able to give signed, written informed consent.
- Subject must have histologically documented, high-grade endometrial cancer.
- 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.
- 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.
What rules you out
- 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.
- Subject has taken a prior cell cycle CHK1 inhibitor, including ACR-368.
- Subject has mesenchymal tumors of the uterus.
- 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.
- Subject had systemic therapy or radiation therapy within 3 weeks prior to the first dose of study drug.
- Subjects has known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is considered uncontrolled based on the criteria included in protocol.
- Subject has a history of clinically meaningful coagulopathy, bleeding diathesis.
- Subject has cardiovascular disease, as defined in the protocol.
- Subject has a history of major surgery within 4 weeks of Screening or a planned major elective surgery during study conduct that would significantly interfere with compliance (dose interruption of >4 weeks).
- Subject has 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.