Skip to main content
Premium Trial:

Request an Annual Quote

Aprea Therapeutics Begins Phase I Trial of WEE1 Inhibitor in Biomarker-Defined Solid Tumors

NEW YORK – Aprea Therapeutics said on Monday it has started treating patients in a Phase I trial of its WEE1 inhibitor APR-1051 in patients with biomarker-defined advanced or metastatic solid tumors.

The ACESOT-1051 trial will include solid tumor patients with amplification or overexpression of CCNE1 or CCNE2 or with deleterious mutations in FBXW7 or PPP2R1A, along with colorectal cancer patients with a KRAS-GLY12 and TP53 co-mutation and uterine serous carcinoma patients regardless of biomarker status.

In the first part of the study, researchers will evaluate three dose levels in 39 patients with advanced solid tumors, followed by a dose optimization portion that will include 40 patients to select the recommended Phase II dose. Aprea CEO Oren Gilad said in a statement that this initial monotherapy study of APR-1051 will "provide the basis for future rational combination treatments."

The firm said it will provide a clinical update on the ACESOT-1051 trial by the end of 2024 and expects to report preliminary efficacy data in 2025.

Earlier this year, Aprea raised $34 million in private placement financing to support development of APR-1051 and its ATR inhibitor ATRN-119. The firm is studying ATRN-119 in a Phase I trial of advanced solid tumors that harbor a DNA damage response mutation.