A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma
brief summary
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.
detailed description
OncoSignature Selected Cohorts (Arms 1 and 2):
Participants in Arms 1 \& 2 will be allocated into two arms based on prospectively predicted sensitivity to ACR-368 using the OncoSignature® Companion Diagnostic test, as follows:
Arm 1: OncoSignature Positive tumors
Arm 2: OncoSignature Negative tumors
OncoSignature Unselected Cohort (Arm 3):
In Arm 3 participants will not require a biopsy or OncoSignature result.
Participants in Arm 1 will receive ACR-368 as monotherapy. Participants in Arms 2 and 3 will receive ACR-368 with ULDG sensitization. Participants in all arms will be treated until disease progression, unacceptable toxicity or any criterion for stopping the study drug or withdrawal from the trial occurs.
Arms 1 and 2 do not apply to sites in the European Union (EU), which will enroll subjects in Arm 3.
official title
A Phase 2 Study of ACR-368 Therapy in Subjects With Endometrial Cancer