Acrivon Therapeutics
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.
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 (completed) OncoSignature Unselected Cohort (Arm 3 \& Arm 4): In Arm 3 and Arm 4, participants will not require a biopsy or OncoSignature result. Participants in Arm 1 and Arm 4 will receive ACR-368 as monotherapy. Participants in Arms 2 and 3 will receive ACR-368 with ULDG sensitization. Par…
Inclusion Criteria: General 1. Participant must be able to give signed, written informed consent. 2. Participant must have histologically documented, high-grade endometrial cancer. Arms 1 and 2 1. All high-grade epithelial endometrial histological subtypes are eligible including: endometrioid (all Grade 3), serous, carcinosarcomas, clear-cell carcinoma, and mixed histologies. Note: Subjects with p53 mutant Grade 2 endometrioid cancer are eligible Arms 3 and 4 2. Serous carcinoma or mixed tumors with a majority component of serous carcinoma or carcinosarcoma where the c…
ACR-368 is an experimental drug
Sensitization of tumor cells is provided through administration of ULDG
Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy