Living for the
moment of Discovery

Our Clinical Trials

At Aprea Therapeutics, we are dedicated to advancing innovative therapies for patients with limited treatment options. Our clinical-stage pipeline includes two promising programs:

APR-1051 – a selective WEE1 inhibitor
ATRN-119 – a first-in-class, macrocyclic ATR inhibitor

Both candidates are designed to disrupt the DNA Damage Response (DDR) pathways that cancer cells rely on for survival, offering a targeted strategy to attack tumors while potentially sparing healthy tissue.

We are actively conducting clinical trials to evaluate the safety and efficacy of these programs in patients with advanced solid tumors, with a particular focus on those harboring specific DNA repair deficiencies.

“We are at the forefront of developing selective DNA Damage Response (DDR) inhibitors, aiming to exploit cancer-specific vulnerabilities and provide transformative treatment options for patients with limited therapeutic choices. Our mission is to turn scientific insight into life-changing solutions.” – Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea.

ACESOT-1051 – WEE1 Clinical Program:

APR-1051

APR-1051 is Aprea’s novel and selective WEE1 inhibitor, currently being evaluated in the ongoing ACESOT-1051 first-in-human Phase 1 clinical trial in patients with advanced or metastatic solid tumors.

ACESOT-1051 trial is registered on ClinicalTrials.gov (NCT06260514) and has clearly defined objectives.
The aim of this Phase 1 first-in-human study is to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of APR-1051 as a single-agent.
Experienced investigators oversee the study
- Including Next Oncology and MD Anderson
Biomarker-driven enrollment: Eligible patients (18 years and older) with advanced/or metastatic solid tumors that harbor the following cancer-associated gene alterations: CCNE1, CCNE2, FBXW7, PPP2R1A, or patients with Colorectal cancer with KRAS^G12/13 and TP53 mutations, or patients with HPV+ Oropharyngeal Squamous Cell Carcinoma, Cervical, Vaginal, or Vulvar Squamous Cell Carcinoma, or patients with Uterine Serous Carcinoma can join the ACESOT-1051 trial.
Preliminary results from the ongoing Phase 1 study provide early clinical proof-of-concept of APR-1051. In addition, APR-1051 has been well tolerated to date.
Additional open-label safety and efficacy data expected in the fourth quarter of 2026
Complete dose escalation expected in the second quarter of 2027

ABOYA-119 – ATR Clinical Program:

ATRN-119

ATRN-119 is Aprea’s first-in-class, macrocyclic ATR inhibitor, evaluated in the ABOYA-119 first-in-human Phase 1/2a clinical trial in patients with advanced or metastatic solid tumors.

Recommended Phase 2 Dose (RP2D) of 1,100mg once daily established in October 2025
Following RP2D determination, Aprea closed this study and is currently exploring combination approaches that may unlock greater clinical benefit. The Company is in discussions with leading academic institutions to evaluate ATRN-119 in combination with radiation in HPV-positive head and neck cancer. The company is also exploring additional investigator-led studies evaluating ATRN-119 with immuno-oncology therapies and antibody-drug conjugates.

Expanded Access
Compassionate Use Policy

Expanded access, also known as compassionate use, may be an option for some individuals with serious or life-threatening conditions, who have exhausted all available medical options and do not qualify for clinical trials. Given the stage of development for our investigational agents, Aprea is currently not offering expanded use programs.

Please continue to monitor clinicaltrials.gov for additional options and our website for changes to our Expanded Use programs.

Consistent with the 21st Century Cures Act, Aprea may revise this Expanded Access policy at any time. This policy applies to all of Aprea’s investigational products.

Living for the moment of Discovery