Phase 2 Study of ACR-368 Alone or With Low-Dose Gemcitabine in Women With Advanced Endometrial Cancer

What this Trial Is About

Researchers are evaluating the efficacy and safety of the experimental drug ACR-368 alone or combined with ultra-low dose gemcitabine ULDG sensitization in participants with high-grade endometrial cancer. This Phase 2 open-label study divides participants into groups based on a test called OncoSignature, which predicts tumor sensitivity to ACR-368. Some groups receive ACR-368 alone while others receive it with ULDG, and treatment continues until disease progresses or unacceptable side effects occur. Participants are assigned to four different arms Arm 1 includes OncoSignature Positive tumors treated with ACR-368 alone Arm 2 includes OncoSignature Negative tumors treated with ACR-368 plus ULDG sensitization Arm 3 and Arm 4 include participants without OncoSignature selection, receiving either ACR-368 with ULDG or ACR-368 alone, respectively. Participants in the European Union are only enrolled in the unselected groups Arms 3 and 4. Treatment is administered continuously until progression, toxicity, or withdrawal. During the study, participants undergo tumor assessments every 8 weeks for up to two years or until death to measure anti-tumor activity. Safety is monitored by recording adverse events and pharmacokinetic testing occurs at specific times during the first treatment cycle. Other outcomes include overall survival, duration of response, and progression-free survival. Participants provide tumor tissue samples either from new biopsies or archival tissue depending on their assigned arm. The study runs from screening through treatment and follow-up until study completion in November 2027.

A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma