Phase 2 Study of Avutometinib Plus Defactinib for Gynecological Cancers

This study is testing two drugs, Avutometinib (VS-6766) and defactinib, to see how well they work and if they are safe for women with certain gynecological cancers. These include endometrioid cancer, mucinous ovarian cancer, high-grade serous ovarian cancer, or other solid gynecological cancers. You may be able to join if your cancer has specific changes (mutations) in genes like RAS or BRAF, or a loss of NF-1 function. The study will look at how many patients respond to the treatment over two years. The drugs are taken by mouth for three weeks, followed by a one-week break, in each four-week cycle.

Study design
This is a Phase 2 study, meaning it's an early-stage study to see if the treatment is effective and safe. It plans to include 55 participants and is an open-label study, so both you and your doctors will know what treatment you are receiving.
What's involved
You will take the study drugs orally and attend regular study visits. These visits will include physical exams, checking vital signs, measuring your tumor size, and providing urine and blood samples. Additional visits may be needed to check for side effects.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at 2 years, which suggests follow-up will occur for at least this long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05512208

A Phase 2 Study of Avutometinib (VS-6766) Plus Defactinib

Recruiting
PHASE2Ages 18–99InterventionalTreatment
University of Oklahoma
~55 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:Avutometinib (VS-6766) + defactinib

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Patients with objective response rate
Measured over 2 years
Endometrioid Cancer
Mucinous Ovarian Cancer
High Grade Serous Ovarian Cancer
Cervical Cancer
Solid Tumor
4 sites across 4 states
Florida1
Louisiana1
New Mexico1
Oklahoma1
  • Christina Washington, MD · PRINCIPAL_INVESTIGATOR · OU Health Stephenson Cancer Center

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  • Proportion of Patients with objective response rate2 years

    To evaluate the efficacy of Avutometinib (VS-6766) + defactinib in endometrioid, MOC, HGSOC and solid gynecological cancer patients with RAS/BRAF/NF1 mutations on confirmed overall response rate (ORR; partial response \[PR\] + complete response \[CR\] defined according to RECIST 1.1) as assessed by the investigator.