The University of Virginia is participating a clinical research study for adults ages 18 and over, who have either platinum-resistant ovarian carcinoma or endometrial adenocarcinoma. If you participate in this study you will either receive the study drug ACR-368 alone (arm 1) or in combination with Gemcitabine (Arm 2). ACR-368, an adenosine triphosphate–competitive selective inhibitor of checkpoint kinase (CHK)1 and CHK2 is an experimental drug.
Participants in the study will be enrolled into one of the following cohorts based on the OnCoSignature result with a newly obtained tumor biopsy from subjects:
• Arm 1, OnCoSignature Positive Monotherapy: ACR-368 alone
o The main purpose of Arm 1 of this study is to investigate how effective ACR-368 is in treating ovarian carcinoma and endometrial adenocarcinoma in a population selected based on subjects who test OncoSignature® Positive.
• Arm 2, OnCoSignature Negative Combination Therapy: ACR-368 and Gemcitabine
o Phase 1b: One of the main purposes of the Phase 1b part of Arm 2 is to assess the safety and tolerability (whether side effects of the study drug can be handled by subjects) of the combination of ACR-368 and gemcitabine.
o Phase 2: The main purpose of the Phase 2 part of Arm 2 is to investigate how effective the combination of ACR-368 and gemcitabine (at the recommended dose from the Phase 1b part) is in treating ovarian carcinoma and endometrial adenocarcinoma in subjects with tumors that are OncoSignature® Negative.
Participants in both arms will be treated until disease progression, unacceptable toxicity or any criterion for stopping the study drug or withdrawal from the trial occurs.
Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.