Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer
M.D. Anderson Cancer Center
Summary
To find the recommended dose of the combination of avutometinib, defactinib, and everolimus in patients with endometrial cancer that is recurrent and has abnormal RAS activity. The safety and effects of this combination will also be studied.
Description
Primary Objectives To identify the recommended phase 2 dosing (RP2D) of the combination of avutometinib, defactinib and everolimus in participants with recurrent, RAS pathway mutant endometrial cancer. Secondary Objectives To evaluate the tolerability of the RP2D of avutometinib, defactinib and everolimus including dose limiting toxicities that occur during cycle 1.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Eligibility Criteria 1. Participants must have histologically or cytologically confirmed recurrent RAS mutant endometrial cancer. RAS pathway gene activating mutations include KRAS, NRAS, HRAS, BRAF, MEK1, and MEK2 activating mutations. Any endometrial histology is permitted, including endometrioid, clear cell, mesonephric, and serous. 2. Participants must have received prior immune checkpoint inhibition treatment alone or in combination. 3. Unlimited prior systemic therapies are allowed, including any number of prior MEK inhibitor therapies is allowed. 4. Ability to understand and the willin…
Interventions
- DrugAvutometinib
Given by PO
- Drugdefactinib
Given by PO
- DrugEverolimus
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas