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OncoMatch/Clinical Trials/NCT05548296

A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma

Is NCT05548296 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including ACR-368 and Gemcitabine for endometrial adenocarcinoma.

Phase 2RecruitingAcrivon TherapeuticsNCT05548296Data as of May 2026

Treatment: ACR-368 · GemcitabineThis 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.

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Extracted eligibility criteria

Cancer type

Endometrial Cancer

Disease stage

Metastatic disease required

Grade: high-grade

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: platinum-based chemotherapy

Subject must have received prior platinum-based chemotherapy

Must have received: anti-PD-1 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 1 week 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

GFR ≥ 50 mL/min/1.73m2 (may be estimated or measured by site standard methods)

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. If associated with Gilbert's syndrome ≤ 3 x ULN is acceptable. Serum albumin ≥ 3 g/dL.

Participant must have adequate organ function at Screening, defined as: Absolute neutrophil count > 1500 cells/µL without growth factor support within 1 week 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 GFR ≥ 50 mL/min/1.73m2. AST and ALT ≤ 3 × 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.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of South Alabama Mitchell Cancer Institute · Mobile, Alabama
  • Alaska Women's Cancer Center · Anchorage, Alaska
  • HonorHealth · Phoenix, Arizona
  • Arizona Oncology Associate, PC- HOPE · Tucson, Arizona
  • University of Arkansas for Medical Sciences · Little Rock, Arkansas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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