GOG-3082 - Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination with Gemcitabine in Adult Subjects with Platinum-Resistant Ovarian Carcinoma Endometrial Adenocarcinoma and Urothelial Carcinoma Based on Acrivon OncoSignature Status

Brief description of study

This is a clinical study to test a drug called ACR-368 (also known as Prexasertib) for the treatment of ovarian, endometrial, and urothelial cancer that has returned and is resistant to platinum-based chemotherapy. The study will test ACR-368 on its own and in combination with a low-dose chemotherapy drug called Gemcitabine.

Patients will be selected for the study based on the results of a test called OncoSignature (a patient selection tumor biopsy test), which will predict how effective ACR-368 will be for each patient. Patients will be allocated to one of two groups based on their OncoSignature result: Arm 1 for patients with a positive OncoSignature result and Arm 2 for patients with a negative or inconclusive OncoSignature result.

In Arm 1, patients with a positive OncoSignature result will receive ACR-368 alone in a Phase 2 study. In Arm 2, patients with a negative or inconclusive OncoSignature result will receive a combination of ACR-368 and low-dose gemcitabine in a Phase 1b study to determine the safe and recommended dose of the combination. A Phase 2 study will then test the combination for effectiveness and safety in each cancer type.


Clinical Study Identifier: s22-01183
ClinicalTrials.gov Identifier: NCT05548296
Principal Investigator: Bhavana Pothuri.
Other Investigators: Kathleen M Lutz, Fabia Brisard Pierrot, Christina Grace Wilson, Minas Platon Economides, Kent Chan, Michelle Diane Swanson Lightfoot, Jaime Lynn Moyles, Edward A Jimenez, Erin Annette Reese, Scot Niglio, Victor Ricardo Adorno Febles, Whitfield B. Growdon, Deanna Gerber, Eva Chalas-Westermann, Caitlin Elizabeth Ryan, Marina Stasenko, Kelly A Levine, Leslie R Boyd, Hank Ng, David R. Wise.


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