A Phase 2 Study of ACR-368 Therapy in Subjects With Endometrial Cancer

Acrivon Therapeutics

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.

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 (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…

Eligibility

Age range: 18+ years
Sex: Female
Healthy volunteers: No

Detailed criteria

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…

Interventions

Drug
ACR-368
ACR-368 is an experimental drug
Drug
Gemcitabine
Sensitization of tumor cells is provided through administration of ULDG
Diagnostic Test
OncoSignature
Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy

Locations (90)

University of South Alabama Mitchell Cancer Institute
Mobile, Alabama
Alaska Women's Cancer Center
Anchorage, Alaska
HonorHealth
Phoenix, Arizona
Arizona Oncology Associate, PC- HOPE
Tucson, Arizona
University of Arkansas for Medical Sciences
Little Rock, Arkansas
City of Hope National Medical Center
Duarte, California