Replay of the Aprea Therapeutics Virtual KOL Event on APR-1051, a Highly Selective and Potentially Best-in-Class Oral WEE1 Inhibitor  Watch here

Clinical Trials Put Discovery Into Action

Every day, Aprea is one step closer to bringing breakthrough DDR-targeted therapies to market.

The goal of clinical trials is to advance our robust pipeline of novel, highly selective therapies to benefit the greatest number of cancer patients possible.

Current Clinical Trials

With our current trial of ATRN-119 and our upcoming trial of APR-1051, we remain steadfast in our commitment to advancing novel therapies that have the potential to make a meaningful difference in the lives of patients who are battling cancer and have limited treatment options.

ABOYA-119 – ATR Clinical Program: ATRN-119

  • ABOYA-119 is an ongoing first-in-human Phase 1 study of ATRN-119 in patients with advanced solid tumors harboring specific DDR mutations (NCT04905914).
  • ATRN-119 is administered daily on a continuous schedule.
  • At the current dose level (550 mg), ATRN-119 is found to be safe and well tolerated with no significant adverse events including DLTs.
  • Pharmacokinetic studies demonstrate:
    • ATRN-119 exhibits near-dose proportional exposure following oral administration.
    • ATRN-119 has a half-life of 4-6 hours.
    • ATRN-119 plasma concentrations are entering the expected therapeutic range at the currently highest dose level (550 mg).
  • The median number of prior lines of treatment was 3 (range: 1 to 13).
  • Preliminary signs of clinical benefit have been observed in the early stages of development.
  • One patient treated at dose level 1 (50 mg) had stable disease on Day 55 and disease progression on Day 112.
  • One patient treated at dose level 3 (200 mg) had stable disease at Days 55, 112, and 168, and continues to be on treatment as of Day 188.
  • View the posters from the AACR conference in April 2024.

ACESOT-1051 – WEE1 Clinical Program: APR-1051

  • The ACESOT-1051 first-in-human study has received FDA approval.
  • The aim of this first-in-human Phase 1 study is to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent APR-1051.
  • This biomarker-driven study will include patients with advanced/metastatic solid tumors harboring cancer-associated gene alterations, such as CCNE1, CCNE2, FBXW7, PPP2R1A, or KRASG12D.
  • Enrollment is anticipated to begin in Q2 2024.
  • MD Anderson Cancer Center is the lead site, and the study will be conducted at three to 10 sites in the U.S.
  • Molecular profiles for cancer-associated gene alterations will be recorded for each patient.
  • ctDNA obtained via blood samples will be collected at designated time points.
  • Evaluations of CTC for protein modifications and/or PBMC will be performed at designated time points.
  • View the posters from the AACR conference in April 2024.

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 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.