Overview for Healthcare Professionals

Phase 2 Trial for Platinum-Resistant Ovarian Cancer

The DENALI Phase 2 study is evaluating a first-in-class WEE1 inhibitor as a potential treatment for platinum-resistant ovarian cancer (PROC).

Below, healthcare professionals can find key details to help evaluate trial eligibility, understand the investigational therapy, and guide conversations with patients.

Eligibility Criteria

This study is enrolling people with ovarian cancer that has recurred within six months of completing platinum-based chemotherapy. Approximately 50% of people with PROC may be eligible.

The trial enrollment is biomarker-driven using available tumor samples that will be tested on the clinical trial diagnostic test to confirm eligibility.

Consider submitting eligible patient samples for Cyclin E1 testing now, even while patients are on current therapy, to ensure rapid identification upon disease progression.

See inclusion criteria below:

  • Age 18+

  • Participants must have ovarian cancer that has recurred within six months of completing platinum-based chemotherapy

  • Tumor testing must confirm a positive Cyclin E1 protein overexpression*

  • Prior therapy:
    • One to 3 prior lines or regimens are allowed (4 prior lines are permitted, if prior mirvetuximab soravtansine)
    • Prior bevacizumab treatment is required, if eligible per standard of care
    • Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care
    • Prior mirvetuximab treatment is required, if eligible per standard of care

*The Phase 1 DENALI trial only included patients with CCNE1 amplification. The Phase 2 study expands eligibility to include all patients with Cyclin E1 protein overexpression, regardless of CCNE1 amplification status.

Mechanism of Action Diagram

Mechanism of Action

First-in-Class WEE1 Inhibitor

The DENALI Phase 2 study therapy is the first and only WEE1 inhibitor being evaluated for PROC in a potentially registrational-enabling trial, a breakthrough that is exciting for many in the scientific community.

The therapy is administered orally and is designed to target cancer based on specific tumor characteristics identified through Cyclin E1 biomarker testing using a companion diagnostic.

WEE1 is a tyrosine kinase with a key role in several stages of the cell cycle, including the G1‑S and G2‑M checkpoints through negative regulation of both CDK1 / 2, preventing replication of cells with damaged DNA¹ ².

WEE1 inhibition results in unscheduled mitosis without adequate DNA repair and eventual cancer cell death¹ ³.

It is a promising target in patients with solid tumors with increased levels of Cyclin E1 protein.
  • Increased levels of Cyclin E1 accelerate the G1‑S transition
  • This results in replication stress, rendering cells even more sensitive to WEE1 inhibition⁴

Patient Experience

If you're considering this trial for your patient, here is what they can expect from participation in the DENALI Phase 2 study:

  • The investigational therapy is administered orally, allowing patients to take the medication at home as part of their routine care.

  • There is no placebo arm in this Phase 2 trial. All participants receive active therapy at one of two dose levels: 300mg or 400mg.

  • No additional biopsy is required, as biomarker testing relies on previously collected tissue samples.

  • With patient consent, physicians should submit previously collected tumor samples for testing with the study’s companion diagnostic to identify patients who may be eligible to participate.

  • Participants will receive care from exceptional clinical teams at leading academic and research institutions across the country.

This information may help your patient feel more confident in discussing whether the DENALI study is an appropriate next step in their treatment journey.

A Commitment to Collaboration

We partner closely with referring physicians and local care teams to ensure coordinated, continuous care throughout the DENALI study. With a focus on clear communication and high-touch support, we are committed to advancing care through trusted clinical collaboration.
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Questions and Patient Referrals

If you would like more detailed trial materials, or have a patient who may qualify, please contact [EMAIL].