Primary Arm 1 Assess the anti-tumor activity of ACR-368 monotherapy in each cohort (ovarian, endometrial, urothelial) of OncoSignature Positive subjects. Arm 2 Assess the safety and tolerability of ACR-368 in combination with LDG Determine the RP2D of LDG Secondary Arm 1 Confirmation of the OncoSignature thresholds for enrichment of ACR368 monotherapy responders. Assess safety and tolerability of ACR-368 monotherapy. Assess efficacy, disease control, survival, and landmarks of survival. Assess RDI every 2 months Assess the PK of ACR-368 in subjects with ovarian carcinoma Assess quality of life. Arm 2 Assess the anti-tumor activity of ACR-368 in combination with LDG Assess efficacy, disease control, survival, and landmarks of survival. Assess RDI every 2 months. Assess the PK of ACR-368 in combination with LDG.
What is the full name of this clinical trial?
ACR-368-201/GOG-3082: A 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