The Phase 2 DENALI study is evaluating a new potential therapy to treat platinum-resistant ovarian cancer (which may also be referred to as PROC).
For people living with this form of ovarian cancer, treatment options are often limited, and new approaches are urgently needed. This trial uses biomarker testing (a special type of testing) to help identify the people most likely to benefit. About 50% of people with PROC may be eligible.
The study treatment is an oral therapy, taken as a pill. This may offer a more convenient option compared to frequent IV infusions.
Because this treatment is investigational and still being studied, it is not yet approved and is only available through clinical trials. The goal of this study is to find out whether this treatment may provide a new option for platinum-resistant ovarian cancer.
Every participant in this study receives therapy. The goal of the DENALI Phase 2 study is to compare different dose levels. This helps researchers understand dosage safety, tolerance, and what will benefit patients the most.
The study is conducted at top institutions across the country, giving access to clinical teams and an opportunity to contribute to scientific discovery.
This trial is designed to fit more easily into your life with:
The DENALI study is evaluating an investigational first-of-its-kind, small molecule, highly selective oral WEE1 kinase inhibitor.
Eligibility is determined by Cyclin E1 protein expression, as assessed by the clinical trial diagnostic test, which helps identify the patients who are most likely to experience benefits from the treatment.
This expands eligibility beyond patients with CCNE1 gene amplifications, opening the door to a broader group who may benefit from this investigational therapy.
About the Investigational Treatment
Evaluating a WEE1 Inhibitor, a New Type of Therapy
Cells in our bodies divide every day as a part of normal growth and repair.
Before a healthy cell divides, it slows down to check for DNA damage.
A protein called WEE1 acts like a brake, giving the cell time to repair any problems before moving forward.
This helps cells stay healthy and function as they should.
Cancer cells often rush through early checkpoints without fixing problems, which causes damage to build up.
But cancer cells can't survive if there's too much DNA damage.
To survive, ovarian cancer cells rely on WEE1 at a later checkpoint. WEE1 slows them down, helping keep the damage at a level the cells can tolerate.
Some ovarian cancer cells have high levels of a protein called Cyclin E1, which drives them to divide even faster and increases damage. This added stress makes the cells more reliant on WEE1 for survival.
Azenosertib is designed to block WEE1. When WEE1 is blocked, the cancer cells don't slow down to repair themselves, and they keep dividing.
Eventually, the damage becomes overwhelming and the cancer cells can't survive.
Wondering if the DENALI trial is right for you?
You may qualify if:
You have ovarian cancer, which has recurred within 6 months of finishing chemotherapy. This is called platinum-resistant ovarian cancer.
You have an over-expression of a protein called Cyclin E1 on your tumor cells.
Use our site locator to quickly identify participating DENALI clinical trial locations in your area.